FDA-Device2026-03-18Class IIPROCESSING DEFECT
Waldemar Link Endo-Model Replacement Plateau screw recalled for detachment hazard
OTHERNationwide distribution
Stop using Waldemar Link Endo-Model Plateau screws
Waldemar Link GmbH & Co. KG is recalling Endo-Model Replacement Plateau screws (Item Number 15-0027/15) because the bushing could detach from the screw shaft due to a crack. This could affect the stability of the implant. Three units with lot number 2549190 were distributed worldwide, including in the U.S., Canada, and Europe.
- If you have received or implanted this device, contact Waldemar Link GmbH & Co. KG immediately.
- Do not use any Endo-Model Replacement Plateau screws with lot number 2549190.
- Consult your orthopedic surgeon or healthcare provider for guidance on replacement or removal.
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
3 units
Manufactured in
Ost Str. 4-10, N/A, Norderstedt, N/A, Germany
Products
Endo-Model Replacement Plateau; Item Number: 15-0027/15;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1512-2026More 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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