FDA-Device2026-03-18Class IIPROCESSING DEFECT
Waldemar Link Endo-Model Replacement Plateau screw recalled for potential bushing detachment
OTHERNationwide distribution
Stop using Waldemar Link Endo-Model Plateau screw
Waldemar Link GmbH & Co. KG is recalling certain Endo-Model Replacement Plateau screws (Item Number 15-8521/15) because the bushing could detach from the screw shaft due to a crack. This could affect the function of the implant. Four units have been identified outside the United States.
- If you received this implant, contact your surgeon or healthcare provider immediately
- Do not use the affected lots: 250805/0020, 250805/0021, 250805/0023, 250805/0024
- Check the device serial/lot number on your implant documentation
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
4 units (OUS only)
Manufactured in
Ost Str. 4-10, N/A, Norderstedt, N/A, Germany
Products
Endo-Model Replacement Plateau; Item Number: 15-8521/15;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1520-2026More 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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