FDA-Device2026-03-18Class IIPROCESSING DEFECT
Waldemar Link Endo-Model Replacement Plateau screw recalled for detaching bushing
What this means
Waldemar Link's Endo-Model Replacement Plateau screws (Item 15-8030/12) may have a bushing that can detach from the screw shaft due to a crack in the screw. This could affect the stability of knee replacement implants. Four units have been identified in this recall, primarily distributed outside the United States.
- Contact your surgeon or orthopedic clinic if you received this implant
- Report the product serial/lot number from your implant records (250721/0194, 0212, 0211, or 0209)
- Follow your healthcare provider's guidance on whether removal or replacement is needed
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
4 units (all OUS)
Manufactured in
Ost Str. 4-10, N/A, Norderstedt, N/A, Germany
Products
Endo-Model Replacement Plateau; Item Number: 15-8030/12;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1517-2026Want us to check the next one for you?
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