Waldemar Link GmbH & Co. KG (Mfg Site)

14 FDA enforcement actions

14 Total Recalls

0 Class I

14 Class II

0 Class III

Firm Details

Product Types: device
States: N/A

All Recalls

Class II: Risk 11/10/2025 device

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: Risk 07/31/2025 device

Some modular LinkSymphoKnee TiNbN Tibial Components were manufactured with two uncoated security screws, which is incorrect.
Class II: Risk 07/15/2025 device

Inconsistent size terminology and color coding used on labeling
Class II: Risk 07/15/2025 device

Inconsistent size terminology and color coding used on labeling
Class II: Risk 04/03/2025 device

The device was delivered with a preassembled Femoral Augment screw that was missing its thread.
Class II: Risk 04/03/2025 device

The device was delivered with a preassembled Femoral Augment screw that was missing its thread.
Class II: Risk 04/03/2025 device

The device was delivered with a preassembled Femoral Augment screw that was missing its thread.
Class II: Risk 04/03/2025 device

The device was delivered with a preassembled Femoral Augment screw that was missing its thread.
Class II: Risk 02/14/2025 device

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: Risk 02/14/2025 device

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: Risk 02/14/2025 device

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: Risk 12/05/2024 device

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).
Class II: Risk 05/22/2024 device

Blind screws of the modular tibial component cannot be loosened intraoperatively,prolongation surgery due to intraoperatively change in procedure, probably to cementing technique
Class II: Risk 05/22/2024 device

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

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.