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Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany

Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany Recalls

All product recalls associated with Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany.

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Recall Summary

Total Recalls

Past Year

Class I (Serious)

Most Recent

Nov 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–20 of 27 recalls

Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Couplin... (Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany) – the device has been delivered with a ... (2025)

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.

FDANov 10, 2025AL, GA, TX• Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany

LinkSymphoKnee System (Waldemar Link) – screw issue (2025)

Some modular LinkSymphoKnee TiNbN Tibial Components were manufactured with two uncoated security screws, which is incorrect.

FDAJul 31, 2025Nationwide• Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany

Plastic Trial Head (Waldemar Link) – Labeling Inconsistency (2025)

Inconsistent size terminology and color coding used on labeling

Page 1 of 2Next

FDA

Jul 15, 2025

Nationwide

• Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany

Prosthesis Head B (Waldemar Link) – Labeling Inconsistency (2025)

Inconsistent size terminology and color coding used on labeling

FDAJul 15, 2025Nationwide• Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany

L-Shaped Femoral Augment (Waldemar Link) – Missing Thread Screw (2025)

The device was delivered with a preassembled Femoral Augment screw that was missing its thread.

FDAApr 3, 2025Nationwide• Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany

Posterior Femoral Augment (Waldemar Link) – Missing Thread Screw (2025)

The device was delivered with a preassembled Femoral Augment screw that was missing its thread.

FDAApr 3, 2025Nationwide• Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany

Tibial Augment (Waldemar Link) – Missing Thread Screw (2025)

The device was delivered with a preassembled Femoral Augment screw that was missing its thread.

FDAApr 3, 2025Nationwide• Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany

Distal Femoral Augment (Waldemar Link) – Missing Thread Screw (2025)

The device was delivered with a preassembled Femoral Augment screw that was missing its thread.

FDAApr 3, 2025Nationwide• Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany

Modular Stem (Waldemar Link) – Carton Label Error (2025)

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.

FDAFeb 14, 2025Nationwide• Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany

LINK MP Reconstruction System (Waldemar Link) – Incorrect Label Size (2024)

Error on the main label and the patient label. The labels indicate a size XXL, this is a standard-size neck segment.. All further information on the labels is correct (Length, CCD and Offset).

FDADec 5, 2024Nationwide• Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany

Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany: Endo Model SL Tibial Components 16-2817/...

Blind screws of the modular tibial component cannot be loosened intraoperatively,prolongation surgery due to intraoperatively change in procedure, probably to cementing technique

FDAMay 22, 2024Nationwide• Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany

Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany: Endo Model M Tibial Components Modular Knee Prosthesis S...

Blind screws of the modular tibial component cannot be loosened intraoperatively,prolongation surgery due to intraoperatively change in procedure, probably to cementing technique

FDAMay 22, 2024Nationwide• Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany

Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany: SPII Model Lubinus, Hip Prosthesis Stem Standard Neck, ce...

Due to two complaints, has come to our attention that additional guidance is required on the correct interpretation of the carton label Size and Type columns to avoid misinterpretation during surgery.

FDAFeb 6, 2024Nationwide• Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany

Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany: SPII Model Lubinus, Long Stem Prosthesis Standard Neck, c...

FDAFeb 6, 2024Nationwide• Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany

Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany: Embrace Drill Tower, Wedged (25mm)

The surgical techniques for the Embrace Shoulder Instruments -Drill Tower (Article REF 645-081/62 & /63) have mixed-up type descriptions ("standard" vs "wedged") in the overview of the instruments.

FDAJan 29, 2024Nationwide• Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany

Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany: Embrace Drill Tower, Standard/Lateral (25mm)

The surgical techniques for the Embrace Shoulder Instruments -Drill Tower (Article REF 645-081/62 & /63) have mixed-up type descriptions ("standard" vs "wedged") in the overview of the instruments.

FDAJan 29, 2024Nationwide• Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany

Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany: LINK BiMobile Dual Mobility System E-Poly Liner for 28mm ...

Mislabeled: Packaging incorrectly reflects a MobileLink Dual Mobility insert type F when it should reference G may cause a delay in surgery

FDAJan 22, 2024Nationwide• Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany

Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany: Link Patella Glide Resection Guide- For the implantation ...

Mislabeled: Angle and height of the device marked as L(large) corresponds to the small/medium dimensions due to a product mix-up. This may result in too little bone material resected and not fit correctly leading to extended surgery time

FDANov 30, 2023Nationwide• Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany

Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany: Link OptiStem Rasp Handle-Used with the OptiStem Rasp to ...

A crack in the weld of the rasp handle may lead to a fracture of the frontal sleeve when the rasp is further impacted or extracted. The rasp remains intact. The rasp would need to be pulled out by a clamp leading to a prolongation of surgery or modified surgery

FDAJul 26, 2023GA, IN, TX• Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany

Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany: MobileLink Acetabular Cup System, Shell/Insert Adapter fo...

Product is labeled with incorrect offset.

FDAJul 14, 2023AL, NV, NJ• Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany