Waldemar Link Gmbh & Co. Kg (mfg Site) Ost Str. 4-10 Norderstedt Germany: Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer
- Recalling firm
- Waldemar Link GmbH & Co. KG (Mfg Site) Ost Str. 4-10 Norderstedt Germany
- Product
- Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07;
- Reason
- The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-01-12
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- 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, Netherlands, Romania, Saudi Arabia.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/231d9882-6059-4fa6-8a78-3b869c659583