Waldemar Link GmbH & Co. KG (Mfg Site)
26 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Waldemar Link GmbH & Co. KG (Mfg Site) and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-04-01FDA-DeviceClass IIEmbrace 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.
- 2026-04-01FDA-DeviceClass IIEmbrace 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.
- 2026-03-18FDA-DeviceClass IIEndo-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.
- 2026-03-18FDA-DeviceClass IIEndo-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.
- 2026-03-18FDA-DeviceClass IIEndo-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.
- 2026-03-18FDA-DeviceClass IIEndo-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.
- 2026-03-18FDA-DeviceClass IIEndo-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.
- 2026-03-18FDA-DeviceClass IIEndo-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.
- 2026-03-18FDA-DeviceClass IIEndo-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.
- 2026-03-18FDA-DeviceClass IIEndo-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.
- 2026-03-18FDA-DeviceClass IIEndo-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.
- 2026-03-18FDA-DeviceClass IIEndo-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.
- 2026-03-18FDA-DeviceClass IIEndo-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.
- 2026-03-18FDA-DeviceClass IIEndo-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.
- 2026-03-18FDA-DeviceClass IIEndo-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.
- 2025-12-17FDA-DeviceClass IIEndo 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.
- 2025-09-17FDA-DeviceClass IILinkSymphoKnee 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.
- 2025-08-20FDA-DeviceClass IIPlastic Trial Head Brown, 7 mm neck length. Item Number: 175-928/15.
Inconsistent size terminology and color coding used on labeling
- 2025-08-20FDA-DeviceClass IIProsthesis Head B, 28 mm, 7 mm neck length. Item Number: 198-828/04.
Inconsistent size terminology and color coding used on labeling
- 2025-05-07FDA-DeviceClass IITibial 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 (
The device was delivered with a preassembled Femoral Augment screw that was missing its thread.
- 2025-05-07FDA-DeviceClass IIL-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.
The device was delivered with a preassembled Femoral Augment screw that was missing its thread.
- 2025-05-07FDA-DeviceClass IIPosterior 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
The device was delivered with a preassembled Femoral Augment screw that was missing its thread.
- 2025-05-07FDA-DeviceClass IIDistal 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
The device was delivered with a preassembled Femoral Augment screw that was missing its thread.
- 2025-03-26FDA-DeviceClass IIModular 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.
- 2025-03-26FDA-DeviceClass IIModular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 12 mm, Product Code: 880-601/12
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.
- 2025-03-26FDA-DeviceClass IIModular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 11 mm, Product Code: 880-601/11
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.
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