FDA-Device2026-03-18Class IIPROCESSING DEFECT
Waldemar Link Endo-Model SL Connection Component recalled for potential bushing detachment
What this means
Waldemar Link GmbH & Co. KG is recalling specific lots of the Endo-Model SL Connection Component with PE-Plateau (Item 16-2840/07) used in orthopedic implants. The bushing on the plateau screw could detach from the screw shaft due to a longitudinal fracture, which could affect implant stability. Thirty-one units have been distributed outside the US.
- Check if you received this implant by verifying the lot number against the recall list (250925/0480, 0481, 0482, etc.)
- Contact your surgeon or Waldemar Link immediately if you have one of the affected lot numbers
- Do not use affected lots for new implant procedures
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
31 units (OUS only)
Manufactured in
Ost Str. 4-10, N/A, Norderstedt, N/A, Germany
Products
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1514-2026Want us to check the next one for you?
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