Z-1670-2023Class II

Smith&Nephew ENGAGE Cementless Partial Knee System, Porous Femoral components, Part Numbers: a) REF...

Name: Z-1670-2023 Smith&Nephew ENGAGE Cementless Partial Knee System, Porous Femoral components, Part Numbers: a) REF...
Creator: Smith & Nephew, Inc.
Published: 2023-05-02
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2023-05-02 / Open, Classified

FDA source

Smith & Nephew, Inc. began a recall of 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... on 2023-05-02. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1670-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-05-02
Posted: 2023-05-31
Recalling firm: Smith & Nephew, Inc.
Product: 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
Product code: HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Reason for recall: 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.
FDA root cause: Under Investigation by firm
Action: Smith & Nephew issued an Urgent Medical Device Recall Notice to its consignees on 05/02/2023 via email and letter. The notice explained the problem and the risk and requested the following: Required Actions: 1. Please inspect your inventory and locate any devices from the listed product and batch numbers enclosed with this Urgent Medical Device Recall Notice, and quarantine them immediately. a. If you are a sales rep, district office, or distributor, you must notify your customers of the field action and ensure that the required actions are complete. b. Include the customer s account number and name in Section A. 2. Please provide a copy of the attached Physician Communication to the surgical staff. The firm is seeking the return of the device.
Quantity in commerce: 1994 units
Distribution: US Nationwide distribution.
Product codes and lots: a) REF 1-10003-100, UDI/DI 00885556872925; b) REF 1-10003-110, UDI/DI 00885556872932; c) REF 1-10003-200, UDI/DI 00885556872949; d) REF 1-10003-210, UDI/DI 00885556872956; e) REF 1-10003-300, UDI/DI 00885556872963; f) REF 1-10003-310, UDI/DI 00885556872970; g) REF 1-10003-400, UDI/DI 00885556872987; h) REF 1-10003-410, UDI/DI 00885556872994; i) REF 1-10003-500, UDI/DI 00885556873007; j) REF 1-10003-510, UDI/DI 00885556873014; k) REF 1-10003-600, UDI/DI 00885556873021; l) REF 1-10003-610, UDI/DI 00885556873038; m) REF 1-10003-700, UDI/DI 00885556873045; n) REF 1-10003-710, UDI/DI 00885556873052; o) REF 1-10003-800, UDI/DI 00885556873069; p) REF 1-10003-810, UDI/DI 00885556873076; ALL BATCHES

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1670-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1670-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-06-07	2023-05-31
Z-1671-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-06-07	2023-05-31
Z-1672-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-06-07	2023-05-31
Z-1673-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-06-07	2023-05-31

Product code HSX

K190439Class IIEngage™ Partial Knee SystemEngage Uni, LLC / cleared 2019-11-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)