FDA-Device2026-03-18Class IIPROCESSING DEFECT
Waldemar Link Endo-Model Replacement Plateau screw recalled for potential bushing detachment
OTHERNationwide distribution
Check Waldemar Link knee implant screw
Waldemar Link GmbH & Co. KG is recalling a specific lot of Endo-Model Replacement Plateau knee implant screws (Item 15-2835/12, Lot 241210/1809). The bushing on the screw can potentially detach from the shaft due to a crack, which could affect the stability of the implant.
- If you received this specific lot number (241210/1809), contact your surgeon or implanting hospital immediately.
- Do not attempt to remove or adjust the implant yourself.
- Your healthcare provider will determine if inspection or replacement is necessary.
Hazard
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
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
1 unit (OUS only)
Manufactured in
Ost Str. 4-10, N/A, Norderstedt, N/A, Germany
Products
Endo-Model Replacement Plateau; Item Number: 15-2835/12;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1515-2026More Waldemar Link GmbH & Co. KG (Mfg Site) recalls
- FDA-Device2026-04-01Waldemar Link Embrace Drill Tower recalled for incorrect article numbers in surgical guide
- FDA-Device2026-04-01Waldemar Link Embrace Drill Tower surgical instructions contain incorrect article numbers
- FDA-Device2026-03-18Waldemar Link Endo-Model Replacement Plateau recalled for potential bushing detachment
- FDA-Device2026-03-18Waldemar Link Endo-Model Replacement Plateau screw recalled for detaching bushing
- FDA-Device2026-03-18Waldemar Link Endo-Model SL Connection Component recalled for potential bushing detachment
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