Waldemar Link GmbH & Co. KG
Norderstedt Schleswig-Holstein, DE
Waldemar Link GmbH & Co. KG appears in FDA device records in Norderstedt Schleswig-Holstein, DE. FDA records list 43 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 65 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Waldemar Link GmbH & Co. KG 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.
- Waldemar Link GmbH & Co. KG (Mfg Site)enforcement report, recall
510(k) clearance history
FDA records hold 43 510(k) clearances for Waldemar Link GmbH & Co. KG between 1978 and 2026. The busiest year on record is 2021, with 7. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1978 | 2 |
| 1979 | 2 |
| 1980 | 1 |
| 1984 | 1 |
| 1985 | 3 |
| 2005 | 1 |
| 2014 | 1 |
| 2015 | 2 |
| 2016 | 1 |
| 2017 | 1 |
| 2018 | 1 |
| 2019 | 6 |
| 2020 | 2 |
| 2021 | 7 |
| 2022 | 5 |
| 2023 | 3 |
| 2024 | 1 |
| 2025 | 2 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K261009 | MobileLink Acetabular Cup System – 40mm ID Inserts (various) | LZO | Substantially Equivalent | |
| K250375 | Allure Hip Stem and Intramedullary Plugs | MEH | Substantially Equivalent | |
| K243927 | MobileLink Acetabular Cup System - inhouse coatings | LZO | Substantially Equivalent | |
| K241636 | MobileLink Acetabular Cup System - Line Extension (Multiple) | LPH | Substantially Equivalent | |
| K231445 | LINK Embrace Shoulder System - Reverse Configuration | PHX | Substantially Equivalent | |
| K222066 | LINK MobileLink Acetabular Cup System | LPH | Substantially Equivalent | |
| K230471 | LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating Surface | JWH | Substantially Equivalent | |
| K213770 | SP-CL Hip Stem and LCU Hip System | LZO | Substantially Equivalent | |
| K221794 | Vario-Cup System | KWY | Substantially Equivalent | |
| K211567 | BiMobile Instruments (for BiMobile Dual Mobility System) | LZO | Substantially Equivalent | |
| K220628 | LINK Endo-Model EVO Knee System | KRO | Substantially Equivalent | |
| K213675 | MP Reconstruction System | LZO | Substantially Equivalent | |
| K212992 | LINK® Embrace Shoulder System - Reverse Configuration | PHX | Substantially Equivalent | |
| K212742 | GEMINI SL Total Knee System, Endo-Model Knee System, and Sled Knee System with LINK PorEx (TiNbN) inhouse coating | JWH | Substantially Equivalent | |
| K211768 | LINK Endo-Model Knee System, Femoral Segments (Augments), UHMWPE | KRO | Substantially Equivalent | |
| K210899 | LINK Embrace Shoulder System- Anatomical Configuration | KWT | Substantially Equivalent | |
| K200607 | LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert Adapters | LPH | Substantially Equivalent | |
| K202924 | LinkSymphoKnee System | JWH | Substantially Equivalent | |
| K200368 | LINK Embrace Shoulder System - Reverse Configuration | PHX | Substantially Equivalent | |
| K201364 | LINK TrabecuLink Femoral Cones | MBH | Substantially Equivalent | |
| K200113 | LINK TrabecuLink Tibial Cones | MBH | Substantially Equivalent | |
| K192559 | Acetabular Bone Screws (for MobileLink Acetabular Cup System) | LZO | Substantially Equivalent | |
| K190535 | BiMobile Dual Mobility System - E-Dur Inserts | LZO | Substantially Equivalent | |
| K191755 | SPAR-K Instruments (for use with Gemini SL Total Knee System) | JWH | Substantially Equivalent | |
| K182321 | MobileLink Acetabular Cup System | LZO | Substantially Equivalent | |
| K182872 | LINK GEMINI SL Total Knee System | JWH | Substantially Equivalent | |
| K183141 | LINK MP Monoblock Hip Prosthesis | LZO | Substantially Equivalent | |
| K171273 | LINK® BiMobile(TM) Dual Mobility System | MEH | Substantially Equivalent | |
| K161840 | LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip System PoroLink® (microporous) and HX® (CaP) coated | LZO | Substantially Equivalent | |
| K152431 | LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System with PorEx (TiNbN) coating | KRO | Substantially Equivalent | |
| K151008 | LINK® MEGASYSTEM-C® | KRO | Substantially Equivalent | |
| K143179 | The LINK® Endo-Model® Knee System | KRO | Substantially Equivalent | |
| K142187 | LINK MP RECONSTRUCTION PROSTHESIS | LZO | Substantially Equivalent | |
| K051826 | BETACONE HIP PROSTHESIS SYSTEM | LWJ | Substantially Equivalent | |
| K852705 | LIDGREN-LUND FEMORAL DYSPLASIA HIP PROSTHESIS SYS | JDI | Substantially Equivalent | |
| K843950 | LINK CEMENTLESS SCREW-IN ACETABULAR CUP | KWA | Substantially Equivalent | |
| K843940 | LINK CEMENTLESS SCREW-IN ACETABULAR CUP | KWA | Substantially Equivalent | |
| K844225 | LINK ACETABULAR MESH | FTM | Substantially Equivalent | |
| K800800 | PATELLAR COMPONENT FOR LUBINUS PATELLAR | HTG | Substantially Equivalent | |
| K792200 | TILLMAN HIP RESURFACING REPLACEMT PROS. | KXA | Substantially Equivalent | |
| K790488 | INTERPLANTA SP TOTAL HIP PROSTHESIS | JDI | Substantially Equivalent | |
| K781735 | ENDOPROSTHESIS SYSTEM, VARIO-HEAD | KWY | Substantially Equivalent | |
| K781490 | TILLMAN HIPSURFACE REPLACEMENT | KXA | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3004371426 | 3003386935 | Waldemar Link GmbH & Co. KG | Oststrasse 4-10, Norderstedt Schleswig-Holstein 22844 DE | 2026 | and 58 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- HWJAwl
- HTWBit, Drill
- GESBlade, Scalpel
- HXYBrace, Drill
- HTQBroach
- KTZCaliper
- JDTCap, Bone
- KDGChisel (Osteotome)
- FZOChisel, Surgical, Manual
- GDJClamp, Surgical, General & Plastic Surgery
- HXQCrimper, Pin
- HTFCurette
- HXZCutter, Wire
- GDIDissector, Surgical, General & Plastic Surgery
- HWRDriver, Prosthesis
- HTEElevator
- HWBExtractor
- HTDForceps
- HTJGauge, Depth
- GDHGouge, Surgical, General & Plastic Surgery
- FZXGuide, Surgical, Instrument
- FZYHammer, Surgical
- GDZHandle, Scalpel
- HXKHolder, Needle; Orthopedic
- GDGHook, Surgical, General & Plastic Surgery
- HWAImpactor
- HWNInstrument, Compression
- HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
- FTMMesh, Surgical
- HRSPlate, Fixation, Bone
- HTCPliers, Surgical
- JDCProsthesis, Elbow, Constrained, Cemented
- JDGProsthesis, Hip, Femoral Component, Cemented, Metal
- KWLProsthesis, Hip, Hemi-, Femoral, Metal
- KWAProsthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
- JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- KROProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
- HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
- HRYProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
- HTGProsthesis, Knee, Hemi-, Patellar Resurfacing, Uncemented
- JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
- KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
- KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
- HWPPunch, Femoral Neck
- HXOPusher, Socket
- HTRRasp
- HTOReamer
- GADRetractor
- HTXRongeur
- HRRScissors, Orthopedic, Surgical
- HXXScrewdriver
- HXRSpatula, Orthopedic
- ILHSplint, Hand, And Components
- HWDStarter, Bone Screw
- GAHStylet, Surgical, General & Plastic Surgery
- HXGTamp
- HWTTemplate
- FSMTray, Surgical, Instrument
- HXCWrench
Recall records
Showing 25 of 65| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2934-2026 | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16 | The affected Endo-Model replacement set for a Rotating Hinge tibial plateau incorrectly contains a Pure Hinge plateau. The incorrect plateau could lead to a prolonged or modified surgery as the plateau cannot be inserted and an alternative product would be needed. If the incorrect plateau were to be implanted, this is associated with increased risk of wear, which could result in a reduced standing time of the implant. | Class II | Open, Classified | |
| Z-1652-2026 | Embrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63; | The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article numbers in the overview of the instruments. However, the individual surgical steps described in the surgical technique are correct. | Class II | Open, Classified | |
| Z-1651-2026 | Embrace Drill Tower, Wedged (25mm); Item Number: 645-081/62; | The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article numbers in the overview of the instruments. However, the individual surgical steps described in the surgical technique are correct. | Class II | Open, Classified | |
| Z-1523-2026 | Endo-Model Replacement Plateau; Item Number: 15-0027/16; | The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. | Class II | Open, Classified | |
| Z-1522-2026 | Endo-Model Replacement Plateau; Item Number: 15-0027/12; | The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. | Class II | Open, Classified | |
| Z-1521-2026 | Endo-Model Replacement Plateau; Item Number: 15-0027/11; | The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. | Class II | Open, Classified | |
| Z-1520-2026 | Endo-Model Replacement Plateau; Item Number: 15-8521/15; | The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. | Class II | Open, Classified | |
| Z-1519-2026 | Endo-Model Replacement Plateau; Item Number: 15-8521/11; | The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. | Class II | Open, Classified | |
| Z-1518-2026 | Endo-Model Replacement Plateau; Item Number: 15-8521/09; | The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. | Class II | Open, Classified | |
| Z-1517-2026 | Endo-Model Replacement Plateau; Item Number: 15-8030/12; | The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. | Class II | Open, Classified | |
| Z-1516-2026 | Endo-Model Replacement Plateau; Item Number: 15-2836/11; | The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. | Class II | Open, Classified | |
| Z-1515-2026 | Endo-Model Replacement Plateau; Item Number: 15-2835/12; | The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. | Class II | Open, Classified | |
| Z-1514-2026 | Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07; | The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. | Class II | Open, Classified | |
| Z-1513-2026 | Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/02; | The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. | Class II | Open, Classified | |
| Z-1512-2026 | Endo-Model Replacement Plateau; Item Number: 15-0027/15; | The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. | Class II | Open, Classified | |
| Z-1511-2026 | Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/05; | The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. | Class II | Open, Classified | |
| Z-0890-2026 | Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Coupling Component, right, modular, L= 68 mm, Taper 10/12. Knee component of limb salvage replacement devices. | The device has been delivered with a preassembled locking screw that had been inserted from the wrong side into the male taper of the femoral component. | Class II | Open, Classified | |
| Z-2541-2025 | LinkSymphoKnee System, Tibial Component, Modular, Symmetric, Sz. 5, CoCrMo/TiNbN, cemented, Fixed. REF Number: 880-100/50 | Some modular LinkSymphoKnee TiNbN Tibial Components were manufactured with two uncoated security screws, which is incorrect. | Class II | Open, Classified | |
| Z-2289-2025 | Plastic Trial Head Brown, 7 mm neck length. Item Number: 175-928/15. | Inconsistent size terminology and color coding used on labeling | Class II | Open, Classified | |
| Z-2288-2025 | Prosthesis Head B, 28 mm, 7 mm neck length. Item Number: 198-828/04. | Inconsistent size terminology and color coding used on labeling | Class II | Open, Classified | |
| Z-1702-2025 | Tibial Augment; Item Numbers: (1) 880-331/11 (Sz. 1-2 - cemented x-sm), (2) 880-331/12 (Sz. 1-2 - cemented sm), (3) 880-331/13 (Sz. 1-2 - cemented md), (4) 880-331/21 (Sz. 1-2 - cemented lg), (5) 880-331/22 (Sz. 1-2 - cemented x-lg), (6) 880-331/23 (Sz. 1-2 - cemented xx-lg), (7) 880-333/11 (Sz. 3-4 - cemented x-sm), (8) 880-333/12 (Sz. 3-4 - cemented sm), (9) 880-333/13 (Sz. 3-4 - cemented md), (10) 880-333/21 (Sz. 3-4 - cemented lg), (11) 880-333/22 (Sz. 3-4 - cemented x-lg), (12) 880-333/23 (Sz. 3-4 - cemented xx-lg), (13) 880-335/11 (Sz. 5-6 - cemented x-sm), (14) 880-335/12 (Sz. 5-6 - cemented sm), (15) 880-335/13 (Sz. 5-6 - cemented md), (16) 880-335/21 (Sz. 5-6 - cemented lg), (17) 880-335/22 (Sz. 5-6 - cemented lg), (18) 880-335/23 (Sz. 5-6 - cemented xx-lg), (19) 880-337/11 (Sz. 7-8 - cemented x-sm), (20) 880-337/12 (Sz. 5-6 - cemented sm), (21) 880-337/13 (Sz. 7-8 - cemented md), (22) 880-337/21 (Sz. 7-8 - cemented lg), (23) 880-337/22 (Sz. 7-8 - cemented x-lg), (24) 880-337/23 (Sz. 7-8 - cemented xx-lg), (25) 880-339/11 (Sz. 9-10 - cemented x-sm), (26) 880-339/12 (Sz. 9-10 - cemented sm), (27) 880-339/13 (Sz. 9-10 - cemented md), (28) 880-339/21 (Sz. 9-10 - cemented lg), (29) 880-339/22 (Sz. 9-10 - cemented x-lg), (30) 880-339/23 (Sz. 9-10 - cemented xx-lg); | The device was delivered with a preassembled Femoral Augment screw that was missing its thread. | Class II | Open, Classified | |
| Z-1701-2025 | L-Shaped Femoral Augment; Item Numbers: (1) 880-320/12 (Sz. 0 - cemented sm), (2) 880-320/22 (Sz. 0 - cemented lg), (3) 880-321/12 (Sz. 1-2 - cemented sm), (4) 880-321/22 (Sz. 1-2 - cemented lg), (5) 880-323/13 (Sz. 3-4 - cemented sm), (6) 880-323/23 (Sz. 3-4 - cemented lg), (7) 880-325/13 (Sz. 5-6 - cemented sm), (8) 880-325/23 (Sz. 5-6 - cemented lg), (9) 880-327/13 (Sz. 7-8 - cemented sm), (10) 880-327/23 (Sz. 7-8 - cemented lg), (11) 880-329/13 (Sz. 9-10 - cemented sm), (12) 880-329/23 (Sz. 9-10 - cemented lg). | The device was delivered with a preassembled Femoral Augment screw that was missing its thread. | Class II | Open, Classified | |
| Z-1700-2025 | Posterior Femoral Augment; Item Numbers: (1) 880-310/11 (Sz. 0 - cemented sm), (2) 880-310/21 (Sz. 0 - cemented lg), (3) 880-311/11 (Sz. 1-2 - cemented sm), (4) 880-311/21 (Sz. 1-2 - cemented lg), (5) 880-313/11 (Sz. 3-4 - cemented sm), (6) 880-313/12 (Sz. 3-4 - cemented md), (7) 880-313/21 (Sz. 3-4 - cemented lg), (8) 880-313/22 (Sz. 3-4 - cemented x-lg), (9) 880-315/11 (Sz. 5-6 - cemented sm), (10) 880-315/12 (Sz. 5-6 - cemented md), (11) 880-315/21 (Sz. 5-6 - cemented lg), (12) 880-315/22 (Sz. 5-6 - cemented x-lg), (13) 880-317/11 (Sz. 7-8 - cemented sm), (14) 880-317/12 (Sz. 7-8 - cemented md), (15) 880-317/21 (Sz. 7-8 - cemented lg), (16) 880-317/22 (Sz. 7-8 - cemented x-lg), (17) 880-319/11 (Sz. 9-10 - cemented sm), (18) 880-319/12 (Sz. 9-10 - cemented md), (19) 880-319/21 (Sz. 9-10 - cemented lg), (20) 880-319/22 (Sz. 9-10 - cemented x-lg). | The device was delivered with a preassembled Femoral Augment screw that was missing its thread. | Class II | Open, Classified | |
| Z-1699-2025 | Distal Femoral Augment; Item Numbers: (1) 880-300/11 (Sz. 0 - cemented sm), (2) 880-300/21 (Sz. 0 - cemented lg), (3) 880-301/11 (Sz. 1-2 - cemented sm), (4) 880-301/21 (Sz. 1-2 - cemented lg), (5) 880-303/11 (Sz. 3-4 - cemented sm), (6) 880-303/12 (Sz. 3-4 - cemented md), (7) 880-303/21 (Sz. 3-4 - cemented lg), (8) 880-303/22 (Sz. 3-4 - cemented x-lg), (9) 880-305/11 (Sz. 5-6 - cemented sm), (10) 880-305/12 (Sz. 5-6 - cemented md), (11) 880-305/21 (Sz. 5-6 - cemented lg), (12) 880-305/22 (Sz. 5-6 - cemented x-lg), (13) 880-307/11 (Sz. 7-8 - cemented sm), (14) 880-307/12 (Sz. 7-8 - cemented md), (15) 880-307/21 (Sz. 7-8 - cemented lg), (16) 880-307/22 (Sz. 7-8 - cemented x-lg), (17) 880-309/11 (Sz. 9-10 - cemented sm), (18) 880-309/12 (Sz. 9-10 - cemented md), (19) 880-309/21 (Sz. 9-10 - cemented lg), (20) 880-309/22 (Sz. 9-10 - cemented x-lg). | The device was delivered with a preassembled Femoral Augment screw that was missing its thread. | Class II | Open, Classified | |
| Z-1374-2025 | Modular Stem cylindrical, Tilastan, press-fit cementless, L= 80 mm, DIA = 13 mm, Product Code: 880-601/13 | A problem was discovered during the scanning process of the outer carton label because of an incorrect GTIN on the label, which is a GTIN for a different product. | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain