Waldemar Link GmbH & Co. KG (Mfg Site) recall records

58 reported ongoing

58 records in this archive. Latest source date Jul 6, 2026.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

FDA device enforcement

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 ...

Class IIReported ongoing

Distribution: Domestic US distribution to Indiana. OUS distribution to Belarus and Germany.

Official source for Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item N...
FDA device enforcement

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 IIReported ongoing

Distribution: US distribution to states of: AL, AZ, FL, GA, IL, IN, KS, KY, LA, MI, NC, OH, OK, TX, VA

Official source for Embrace Drill Tower, Wedged (25mm); Item Number: 645-081/62;
FDA device enforcement

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 IIReported ongoing

Distribution: US distribution to states of: AL, AZ, FL, GA, IL, IN, KS, KY, LA, MI, NC, OH, OK, TX, VA

Official source for Embrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63;
FDA device enforcement

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 IIReported ongoing

Distribution: Worldwide - US Nationwide distribution in the state of NJ and the countries of Belarus, Canada, Switzerland , Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Ne...

Official source for Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/05;
FDA device enforcement

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 IIReported ongoing

Distribution: Worldwide - US Nationwide distribution in the state of NJ and the countries of Belarus, Canada, Switzerland , Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Ne...

Official source for Endo-Model Replacement Plateau; Item Number: 15-0027/15;
FDA device enforcement

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 IIReported ongoing

Distribution: Worldwide - US Nationwide distribution in the state of NJ and the countries of Belarus, Canada, Switzerland , Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Ne...

Official source for Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/02;
FDA device enforcement

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 IIReported ongoing

Distribution: Worldwide - US Nationwide distribution in the state of NJ and the countries of Belarus, Canada, Switzerland , Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Ne...

Official source for Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07;
FDA device enforcement

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 IIReported ongoing

Distribution: Worldwide - US Nationwide distribution in the state of NJ and the countries of Belarus, Canada, Switzerland , Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Ne...

Official source for Endo-Model Replacement Plateau; Item Number: 15-2835/12;
FDA device enforcement

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 IIReported ongoing

Distribution: Worldwide - US Nationwide distribution in the state of NJ and the countries of Belarus, Canada, Switzerland , Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Ne...

Official source for Endo-Model Replacement Plateau; Item Number: 15-2836/11;
FDA device enforcement

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 IIReported ongoing

Distribution: Worldwide - US Nationwide distribution in the state of NJ and the countries of Belarus, Canada, Switzerland , Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Ne...

Official source for Endo-Model Replacement Plateau; Item Number: 15-8030/12;
FDA device enforcement

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 IIReported ongoing

Distribution: Worldwide - US Nationwide distribution in the state of NJ and the countries of Belarus, Canada, Switzerland , Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Ne...

Official source for Endo-Model Replacement Plateau; Item Number: 15-8521/09;
FDA device enforcement

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 IIReported ongoing

Distribution: Worldwide - US Nationwide distribution in the state of NJ and the countries of Belarus, Canada, Switzerland , Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Ne...

Official source for Endo-Model Replacement Plateau; Item Number: 15-8521/11;
FDA device enforcement

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 IIReported ongoing

Distribution: Worldwide - US Nationwide distribution in the state of NJ and the countries of Belarus, Canada, Switzerland , Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Ne...

Official source for Endo-Model Replacement Plateau; Item Number: 15-8521/15;
FDA device enforcement

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 IIReported ongoing

Distribution: Worldwide - US Nationwide distribution in the state of NJ and the countries of Belarus, Canada, Switzerland , Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Ne...

Official source for Endo-Model Replacement Plateau; Item Number: 15-0027/11;
FDA device enforcement

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 IIReported ongoing

Distribution: Worldwide - US Nationwide distribution in the state of NJ and the countries of Belarus, Canada, Switzerland , Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Ne...

Official source for Endo-Model Replacement Plateau; Item Number: 15-0027/12;
FDA device enforcement

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 IIReported ongoing

Distribution: Worldwide - US Nationwide distribution in the state of NJ and the countries of Belarus, Canada, Switzerland , Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Ne...

Official source for Endo-Model Replacement Plateau; Item Number: 15-0027/16;
FDA device enforcement

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 IIReported ongoing

Distribution: US distribution to states of: AL, GA, and TX.

Official source for Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Coupling Component, right, modular, L= 68 mm, T...
FDA device enforcement

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 IIReported ongoing

Distribution: Worldwide - US Nationwide distribution in the states of CO, IN, NJ, TX and the countries of Germany and Italy.

Official source for LinkSymphoKnee System, Tibial Component, Modular, Symmetric, Sz. 5, CoCrMo/TiNbN, cemented, Fixed...

Reasons in these listed records

  • 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 incor...
  • 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.
  • The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
  • 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.

These examples come from this result page and are not a ranking of every recall reason.

Checking Waldemar Link GmbH & Co. KG (Mfg Site)

Is there a recall on waldemar link gmbh & co. kg (mfg site) right now?

This archive contains 58 records, including 58 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

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What if the search finds no matching record?

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Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

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