FDA-Device2026-03-18Class IIPROCESSING DEFECT
Waldemar Link Endo-Model Replacement Plateau recalled for detachable bushing screw
What this means
Waldemar Link GmbH & Co. KG is recalling specific lots of the Endo-Model Replacement Plateau (Item 15-0027/16), a surgical implant used in joint replacement procedures. The bushing on the plateau screw may detach from the screw shaft due to a crack, which could affect the implant's stability during or after surgery.
- If you received this implant, contact your surgeon or healthcare provider immediately to determine if your device is affected.
- Do not undergo any procedure using this implant if your lot number matches: 2550412, 2550413, or 2549228.
- Your surgeon can verify the lot number on your implant paperwork or device packaging.
The agency's original wording
Hazard
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
Intended for
Adults
Illnesses reported
None reported
Sold states
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.
Affected count
3 units (OUS only)
Manufactured in
Ost Str. 4-10, N/A, Norderstedt, N/A, Germany
Products
Endo-Model Replacement Plateau; Item Number: 15-0027/16;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1523-2026Want us to check the next one for you?
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