Smith & Nephew, Inc.

Memphis, TN, US

SMITH & NEPHEW INC. appears in FDA device records in Memphis, TN. FDA records list 572 510(k) clearances between 1980-08-13 and 2026-07-09, 161 PMA records and 8 registered establishments. As of 2026-09-10, FDA records show 610 recalls for this company, and at least one establishment registration is current.

510(k) clearances: 572
PMA records: 161
Recall records: 610
Registered establishments: 8

FDA records under these names

3 names

FDA records resolved to Smith & Nephew, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

Smith & Nephew Inc., Endoscopy Div.510(k), enforcement report, recall
Smith & Nephew Inc., Endoscopy Division510(k), enforcement report, recall
Smith And Nephew, Inc. Wound Management Divisionrecall

510(k) clearance history

Showing 50 of 572

FDA records hold 572 510(k) clearances for Smith & Nephew, Inc. between 1980 and 2026. The busiest year on record is 2003, with 28. The most recent is 2026, with 3.

Clearances by year, as a table

510(k) clearance decisions for Smith & Nephew, Inc., by decision year
Year	Clearances
1980	1
1981	1
1982	2
1983	4
1984	3
1985	2
1986	6
1987	8
1988	1
1989	2
1990	1
1991	2
1992	1
1994	7
1995	2
1996	1
1997	12
1998	14
1999	15
2000	17
2001	15
2002	27
2003	28
2004	25
2005	24
2006	20
2007	24
2008	26
2009	25
2010	26
2011	27
2012	26
2013	19
2014	11
2015	19
2016	13
2017	18
2018	11
2019	9
2020	13
2021	13
2022	13
2023	14
2024	14
2025	7
2026	3

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K261968	Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982)	MBI	Substantially Equivalent	2026-07-09
DEN250037	TESSA Spatial Surgery System; INTELLIO Tablet (72205455)	SIQ	Unknown	2026-07-06
K254084	AETOS Shoulder System - CONCELOC Glenoids	KWS	Substantially Equivalent	2026-04-06
K252416	AETOS Shoulder System Meta Humeral Prosthesis Size 0	KWS	Substantially Equivalent	2025-10-29
K252129	AETOS Shoulder System Stemless Humeral Prosthesis	PKC	Substantially Equivalent	2025-10-03
K251627	BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (white); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid blue)	MBI	Substantially Equivalent	2025-06-25
K243608	TRIGEN Stable Lock Nut & Washer	JDS	Substantially Equivalent	2025-06-12
K250677	LEGION Total Knee System	JWH	Substantially Equivalent	2025-04-02
K250571	CATALYSTEM Femoral Stems	LZO	Substantially Equivalent	2025-03-28
K241666	EVOS Pelvic and Acetabular System	HRS	Substantially Equivalent	2025-02-19
K243364	TRIGEN META-TAN Trochanteric Antegrade Nail	HSB	Substantially Equivalent	2024-12-09
K242631	REGENETEN™ Bioinductive Implant	OWY	Substantially Equivalent	2024-11-26
K240716	AETOS Shoulder System Stemless Humeral Prosthesis	PKC	Substantially Equivalent	2024-11-20
K242711	JOURNEY II Unicompartmental Knee System (JOURNEY II UK)	HSX	Substantially Equivalent	2024-10-30
K240783	Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems	JDI	Substantially Equivalent	2024-10-21
K242375	OR3O Dual Mobility System	LPH	Substantially Equivalent	2024-10-07
K240061	TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System	JDS	Substantially Equivalent	2024-09-20
K240487	EVOS Patella Plates	HRS	Substantially Equivalent	2024-09-03
K241804	TRIGEN INTERTAN 10S Nail System	JDS	Substantially Equivalent	2024-08-22
K240381	CATALYSTEM Femoral Stems	LZO	Substantially Equivalent	2024-06-27
K241435	Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, co-braid-blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one MINITAPE suture, blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one MINITAPE suture, co-braid-blue	MBI	Substantially Equivalent	2024-06-20
K240113	CORIOGRAPH Knee Pre-Op Plan	PBF	Substantially Equivalent	2024-03-18
K233949	ACCORD Cable System	JDQ	Substantially Equivalent	2024-03-13
K233730	Footprint Mini PK, 3.5mm Suture Anchor	MBI	Substantially Equivalent	2024-01-17
K233396	Cannulated Screw System	HWC	Substantially Equivalent	2023-12-21
K232667	OR3O Dual Mobility Liners	LPH	Substantially Equivalent	2023-10-27
K232457	Q-FIX ULTRA All-Suture Anchor	MBI	Substantially Equivalent	2023-09-08
K231376	Q-FIX With Needles (Q-FIX With Needles, #0 Suture & Q-FIX With Needles, Minitape)	MBI	Substantially Equivalent	2023-08-09
K232005	HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue); HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue Cobraid)	MBI	Substantially Equivalent	2023-08-04
K231448	TANDEM Hip System	LZY	Substantially Equivalent	2023-07-19
K230761	TRIGEN META-NAIL Nail System	JDS	Substantially Equivalent	2023-06-14
K230572	AETOS Shoulder System	KWS	Substantially Equivalent	2023-06-07
K223762	Smith & Nephew ACCORD™ Cable System	HRS	Substantially Equivalent	2023-05-30
K222501	Regeneten Bioinductive Implant	OWY	Substantially Equivalent	2023-05-11
K230653	Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and II Knee Systems, JOURNEY II CR Knee System, JOURNEY II Uni Knee System, Journey II UK Knee System, JOURNEY II XR Bi-Cruciate Retaining Knee System, JOURNEY PFJ System, JOURNEY Uni Knee System, Legion Hinge Total Knee System, Legion Total Knee System, ZUK Unicompartmental Knee System, ENGAGE Partial Knee System and Porous Patella and Porous Tibial Baseplates	JWH	Substantially Equivalent	2023-05-04
K230555	Cemented Tibia Baseplate no Taper with JRNY Lock	JWH	Substantially Equivalent	2023-03-30
K222971	ULTRABUTTON QUAD Adjustable Fixation Device; ULTRABUTTON BB Adjustable Fixation Device; ULTRABUTTON TIB SMALL Adjustable Fixation Device; ULTRABUTTON TIB MEDIUM Adjustable Fixation Device; ULTRABUTTON TIB LARGE Adjustable Fixation Device	MBI	Substantially Equivalent	2023-02-17
K220847	AETOS Shoulder System	KWS	Substantially Equivalent	2023-01-03
K223112	MAVERICK Mini External Fixation System	JDW	Substantially Equivalent	2022-12-08
K210980	Smith & Nephew Intramedullary Nail Systems	HSB	Substantially Equivalent	2022-11-14
K221740	SMITH & NEPHEW INTELLIO 4K CAMERA CONTROL UNIT, NETWORK ENABLED (72205447), SMITH & NEPHEW INTELLIO 4K CAMERA CONTROL UNIT, NON-NETWORK ENABLED (72205448)	GCJ	Substantially Equivalent	2022-10-20
K213123	EVOS Wrist Spanning Plate	HRS	Substantially Equivalent	2022-10-18
K213126	Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP Mini-Mod, Compression Hip Screw (CHS), CONQUEST FN, and cannulated screws	JDO	Substantially Equivalent	2022-09-29
K221792	Acute QC Strut and Components	OSN	Substantially Equivalent	2022-08-25
K220959	OR3O Dual Mobility System	LPH	Substantially Equivalent	2022-08-18
K221939	Cemented Round Patella with JRNY Pegs	JWH	Substantially Equivalent	2022-07-26
K211176	Smith & Nephew Hip Systems	LPH	Substantially Equivalent	2022-07-01
K220896	Legion Inserts with JRNY Lock	JWH	Substantially Equivalent	2022-04-26
K213827	TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral Resurfacing Arthroplasty System (HRA), Modular Radial Head System (MRH), Katalyst Bipolar Radial Head System (Katalyst)	KWS	Substantially Equivalent	2022-03-11
K213874	MAVERICK External Fixation System	JDW	Substantially Equivalent	2022-02-11

Registered establishments

FDA registered establishments for Smith & Nephew, Inc., with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
1219602	1219602	SMITH & NEPHEW INC.	ENDOSCOPY, MANSFIELD, MA 02048 US	2026	FEI FRL FRN FSM FWZ FZX GAE GAS GAT GCJ and 41 more, listed in full below
1643264	1643264	SMITH & NEPHEW INC.	ENDOSCOPY, OKLAHOMA CITY, OK 73107 US	2026	CCX EMX EOB FEI FET FFS FLN FQH FRG FSM and 99 more, listed in full below
3003604053	3003604053	SMITH & NEPHEW INC.	ENDOSCOPY, ANDOVER, MA 01810 US	2026	CCX EOB FCX FEI FFS FLN FRG FRL FSM FTM and 56 more, listed in full below
1020279	1020279	SMITH & NEPHEW, INC.	1450 BROOKS RD., MEMPHIS, TN 38116 US	2026	FNS FQH FSM FTY FZO FZP FZX FZY GAD GDG and 128 more, listed in full below
3005551626	3005551626	SMITH & NEPHEW, INC.	6409 E Holmes Rd, Memphis, TN 38141 US	2026	HSX JDI JWH KRO KRR KWL KWY KWZ LPH LWJ and 4 more, listed in full below
3007366790	3007282753	Smith & Nephew, Inc.	3303 E Holmes Rd, Memphis, TN 38118 US	2026	FNS FQH FSM FTY FZO FZP FZX FZY GAD GDG and 103 more, listed in full below
3010034780	3010034780	Smith & Nephew, Inc.	2225 Cedars Rd Ste A, Lawrenceville, GA 30043 US	2026	BTA BYH FON FQH FRO FTL KGT KGX KGZ KMF and 9 more, listed in full below
3038503932	3038503932	Smith & Nephew, Inc.	4340 Swinnea Rd, Memphis, TN 38118 US	2026	FNS FQH FSM FTY FZO FZP FZX FZY GAD GAT and 92 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Showing 25 of 610

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-2456-2026	TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816	Humeral nail due to a manufacturing error is missing distal holes and if implanted may lead to revision surgery but, if the missing holes are identified before implantation, an equivalent backup can be used, or a bent nail of the same size, which would require additional surgical steps to address soft tissue/bone preparation, which could lead to a surgical delay of greater than 30 minutes.	Class II	2026-03-16	Open, Classified
Z-0957-2026	BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.	Removal of affected lot of screws due to labeling error.	Class II	2025-11-24	Open, Classified
Z-1806-2025	META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690	Integrated Lag/Compression Screw Kit has a compression screw with hexagon socket that may be undersized, which causes the screw to be non-functional, which would require replacement with another adequate size screw, and exchange may exceed 30 minutes.	Class II	2025-03-18	Open, Classified
Z-0581-2025	BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.	Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device.	Class II	2024-10-29	Open, Classified
Z-0326-2025	Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile, femoral head bipolar component of the Tandem Bipolar Hip System.	The Bipolar assembly contains an oversized Retainer Ring.	Class II	2024-10-15	Open, Classified
Z-0282-2025	smith&nephew LEGION OXINIUM POSTERIOR STABILIZED NONPOROUS FEMORAL COMPONENT, SIZE 5N, RIGHT, NARROW, REF 71421275; Uncoated knee femur prosthesis, metallic	Complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 5N RIGHT implant instead of a GENESIS II POSTERIOR STABILIZED FEMORAL SIZE 5 LEFT as described on the product label.	Class II	2024-10-02	Open, Classified
Z-0281-2025	smith&nephew GENESIS II NONPOROUS POSTERIOR STABILIZED FEMORAL COMPONENT, SIZE 5 LEFT, REF 71421015; Uncoated knee femur prosthesis, metallic	Complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 5N RIGHT implant instead of a GENESIS II POSTERIOR STABILIZED FEMORAL SIZE 5 LEFT as described on the product label.	Class II	2024-10-02	Open, Classified
Z-0278-2025	smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 4 LEFT, REF 71421164; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER	Complaint received indicating that a package contained a LGN OX CONSTRAINED FEM 3 LT implant instead of a LGN OX CONSTRAINED FEM 4 LT as described on the product label.	Class II	2024-10-02	Open, Classified
Z-0277-2025	smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 3 LEFT, REF 71421163; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER	Complaint received indicating that a package contained a LGN OX CONSTRAINED FEM 3 LT implant instead of a LGN OX CONSTRAINED FEM 4 LT as described on the product label.	Class II	2024-10-02	Open, Classified
Z-3097-2024	ROTATION MEDICAL TENDON STAPLES (8) (narrow indication)-Intended for fixation of prosthetic material to soft tissues. Product Number: 72205201	Product packaging process may result in an improper or incomplete seal of the outer foil pouch surrounding the inner Tyvek pouch, compromising product sterility	Class II	2024-08-12	Open, Classified
Z-3096-2024	ROTATION MEDICAL TENDON STAPLES (8) (broad indication)-Intended for fixation of prosthetic material to soft tissues. Product Number: 2504-1	Product packaging process may result in an improper or incomplete seal of the outer foil pouch surrounding the inner Tyvek pouch, compromising product sterility	Class II	2024-08-12	Open, Classified
Z-3172-2024	DIAMOND POINT, BOTH ENDS K-WIRE, REF 128062, metallic bone fixation fastener	Smith & Nephew, Inc., has initiated a field action to voluntarily remove two batches of K-Wires due to a packaging error. A complaint was received indicating that a package contained K-WIRE .062X9 2PT DM wires instead of K-WIRE .045X9 2PT DM as described on the product label.	Class II	2024-07-09	Open, Classified
Z-3171-2024	DIAMOND POINT, BOTH ENDS K-WIRE, REF 128042, metallic bone fixation fastener	Smith & Nephew, Inc., has initiated a field action to voluntarily remove two batches of K-Wires due to a packaging error. A complaint was received indicating that a package contained K-WIRE .062X9 2PT DM wires instead of K-WIRE .045X9 2PT DM as described on the product label.	Class II	2024-07-09	Open, Classified
Z-1901-2024	smith&nephew OXINIUM Femoral Head 12/14 Taper, REF 71343204, 32 MM OD +4, Sterile; and smith&nephew, 12/14 Taper, REF 71343604, 36 MM M / +4	Packaging contained the incorrect size of femoral head from what was displayed on the label.	Class II	2024-04-24	Open, Classified
Z-0158-2024	JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 74029262; knee prosthesis	The JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM. And also, a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM.	Class II	2023-09-27	Open, Classified
Z-0157-2024	JOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6, REF 74027262; knee prosthesis	The JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM. And also, a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM.	Class II	2023-09-27	Open, Classified
Z-2621-2023	smith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, SIZE 5N, LEFT, NARROW, REF 71421265; knee joint	The firm conducting a recall due to a complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 4N LT implant instead of a LEGION NARROW PSvOXIN SZ 5N LT as described on the product label.	Class II	2023-08-31	Open, Classified
Z-2444-2023	TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT, REF 71647340, Femur nail	A complaint was received indicating that a package contained a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT implant instead of a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT as described on the product label.	Class II	2023-07-24	Open, Classified
Z-2443-2023	TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT, REF 71647336, Femur nail	A complaint was received indicating that a package contained a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT implant instead of a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT as described on the product label.	Class II	2023-07-24	Open, Classified
Z-1673-2023	Smith&Nephew ENGAGE Cementless Partial Knee System, Coated Tibial Insert, Part Numbers: a) REF 1-10013-109, SIZE 1-LEFT MED, 9MM; b) REF 1-10013-110, SIZE 1-LEFT MED, 10MM; c) REF 1-10013-111, SIZE 1-LEFT MED, 11MM; d) REF 1-10013-113, SIZE 1-LEFT MED, 13MM; e) REF 1-10013-159, SIZE 1-RIGHT MED, 9MM; f) REF 1-10013-160, SIZE 1-RIGHT MED, 10MM; g) REF 1-10013-161, SIZE 1-RIGHT MED, 11MM; h) REF 1-10013-163, SIZE 1-RIGHT MED, 13MM; i) REF 1-10013-209, SIZE 2-LEFT MED, 9MM; j) REF 1-10013-210, SIZE 2-LEFT MED, 10MM; k) REF 1-10013-211, SIZE 2-LEFT MED, 11MM; l) REF 1-10013-213, SIZE 2-LEFT MED, 13MM; m) REF 1-10013-259, SIZE 2-RIGHT MED, 9MM; n) REF 1-10013-260, SIZE 2-RIGHT MED, 10MM; o) REF 1-10013-261, SIZE 2-RIGHT MED, 11MM; p) REF 1-10013-263, SIZE 2-RIGHT MED, 13MM; q) REF 1-10013-309, SIZE 3-LEFT MED, 9MM; r) REF 1-10013-310, SIZE 3-LEFT MED, 10MM; s) REF 1-10013-311, SIZE 3-LEFT MED, 11MM; t) REF 1-10013-313, SIZE 3-LEFT MED, 13MM; u) REF 1-10013-359, SIZE 3-RIGHT MED, 9MM; v) REF 1-10013-360, SIZE 3-RIGHT MED, 10MM; w) REF 1-10013-361, SIZE 3-RIGHT MED, 11MM; x) REF 1-10013-363, SIZE 3-RIGHT MED, 13MM; y) REF 1-10013-409, SIZE 4-LEFT MED, 9MM; z) REF 1-10013-410, SIZE 4-LEFT MED, 10MM; aa) REF 1-10013-411, SIZE 4-LEFT MED, 11MM; bb) REF 1-10013-413, SIZE 4-LEFT MED, 13MM; cc) REF 1-10013-459, SIZE 4-RIGHT MED, 9MM; dd) REF 1-10013-460, SIZE 4-RIGHT MED, 10MM; ee) REF 1-10013-461, SIZE 4-RIGHT MED, 11MM; ff) REF 1-10013-463, SIZE 4-RIGHT MED, 13MM; gg) REF 1-10013-509, SIZE 5-LEFT MED, 9MM; hh) REF 1-10013-510, SIZE 5-LEFT MED, 10MM; ii) REF 1-10013-511, SIZE 5-LEFT MED, 11MM; jj) REF 1-10013-513, SIZE 5-LEFT MED, 13MM; kk) REF 1-10013-559, SIZE 5-RIGHT MED, 9MM; ll) REF 1-10013-560, SIZE 5-RIGHT MED, 10MM; mm) REF 1-10013-561, SIZE 5-RIGHT MED, 11MM; nn) REF 1-10013-563, SIZE 5-RIGHT MED, 13MM; oo) REF 1-10013-609, SIZE 6-LEFT MED, 9MM; pp) REF 1-10013-610, SIZE 6-LEFT MED, 10MM; qq) REF 1-10013-611, SIZE 6-LEFT MED, 11MM; rr) REF 1-10013-613, SIZE 6-LEFT MED, 13MM; ss) REF 1-10013-659, SIZE 6-RIGHT MED, 9MM; tt) REF 1-10013-660, SIZE 6-RIGHT MED, 10MM; uu) REF 1-10013-661, SIZE 6-RIGHT MED, 11MM; vv) REF 1-10013-663, SIZE 6-RIGHT MED, 13MM; Unicondylar knee prothesis	Recent complaint data indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement registries. The data identifies a potential signal that the performance is an outlier versus the state of the art with respect to the risk for revision.	Class II	2023-05-02	Open, Classified
Z-1672-2023	Smith&Nephew ENGAGE Cementless Partial Knee System, Coated Tibial Tray, Part Numbers: a) REF 1-10012-100, SIZE 1-LEFT MEDIAL; b) REF 1-10012-150, SIZE 1-RIGHT MEDIAL; c) REF 1-10012-200, SIZE 2-LEFT MEDIAL; d) REF 1-10012-250, SIZE 2-RIGHT MEDIAL; e) REF 1-10012-300, SIZE 3-LEFT MEDIAL; f) REF 1-10012-350, SIZE 3-RIGHT MEDIAL; g) REF 1-10012-400, SIZE 4-LEFT MEDIAL; h) REF 1-10012-450, SIZE 4-RIGHT MEDIAL; i) REF 1-10012-500, SIZE 5-LEFT MEDIAL; j) REF 1-10012-550, SIZE 5-RIGHT MEDIAL; k) REF 1-10012-600, SIZE 6-LEFT MEDIAL; l) REF 1-10012-650, SIZE 6-RIGHT MEDIAL; Unicondylar knee prothesis	Recent complaint data indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement registries. The data identifies a potential signal that the performance is an outlier versus the state of the art with respect to the risk for revision.	Class II	2023-05-02	Open, Classified
Z-1671-2023	Smith&Nephew ENGAGE Cementless Partial Knee System, Tibial Anchor Stem, Part Numbers: a) REF 1-10011-100 (SIZE 1-2), b) REF 1-10011-200 (SIZE 3-4), c) REF 1-10011-300 (SIZE 5-6); Unicondylar knee prothesis	Recent complaint data indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement registries. The data identifies a potential signal that the performance is an outlier versus the state of the art with respect to the risk for revision.	Class II	2023-05-02	Open, Classified
Z-1670-2023	Smith&Nephew ENGAGE Cementless Partial Knee System, Porous Femoral components, Part Numbers: a) REF 1-10003-100 (SIZE 1 Right Medial); b) REF 1-10003-110 (SIZE 1 Left Medial); c) REF 1-10003-200 (SIZE 2-Right Medial); d) REF 1-10003-210 (SIZE 2-Left Medial); e) REF 1-10003-300 (SIZE 3- Right Medial); f) REF 1-10003-310 (SIZE 3- Left Medial); g) REF 1-10003-400 (SIZE 4- Right Medial); h) REF 1-10003-410 (SIZE 4- Left Medial); i) REF 1-10003-500 (SIZE 5- Right Medial); j) REF 1-10003-510 (SIZE 5- Left Medial); k) REF 1-10003-600 (SIZE 6- Right Medial); l) REF 1-10003-610 (SIZE 6- Left Medial); m) REF 1-10003-700 (SIZE 7- Right Medial); n) REF 1-10003-710 (SIZE 7- Left Medial); o) REF 1-10003-800, (SIZE 8 - Right Medial); p) REF 1-10003-810, (SIZE 8 - Left Medial); Unicondylar knee prothesis	Recent complaint data indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement registries. The data identifies a potential signal that the performance is an outlier versus the state of the art with respect to the risk for revision.	Class II	2023-05-02	Open, Classified
Z-1393-2023	JOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 7-8 8MM	A mispack occurred during the manufacturing process, resulting in the box incorrectly containing JOURNEY II UNI Tibia Insert Medical Size 1-2 12MM instead of the JOURNEY II UNI Tibia Insert Medial Size 7-8 8MM.	Class II	2023-03-27	Open, Classified
Z-1418-2022	(1) Genesis II Non-Porous Tibial Baseplate Size 5 Right, Product #71420186. (2) Genesis II Non-Porous Tibial Baseplate Size 4 Left, Product #71420166.	The product was mispackaged (swapped). The devices within the inner tray matches the inner tray but does not match the outer box label and the chart sticks.	Class II	2022-06-27	Terminated

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

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Claiming lets Smith & Nephew, Inc. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.

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Data as of 2026-09-28, FDA export datePage updated 2026-09-06Source: openFDA, public domain