FDA-Device2026-03-18Class IIPROCESSING DEFECT
Waldemar Link Endo-Model Replacement Plateau recalled for potential bushing detachment
OTHERNationwide distribution
Check your Endo-Model Replacement Plateau implant
Waldemar Link GmbH & Co. KG is recalling the Endo-Model Replacement Plateau (Item Number 15-0027/11) because the bushing on the plateau screw could detach from the screw shaft due to a crack. This could affect the stability of the implant. Two units outside the US have been identified, with no injuries reported to date.
- If you received this implant, contact your surgeon or healthcare provider immediately
- Do not delay—inform them of the recall and discuss next steps for your care
- Your provider may recommend monitoring or further evaluation
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
2 units (OUS only)
Manufactured in
Ost Str. 4-10, N/A, Norderstedt, N/A, Germany
Products
Endo-Model Replacement Plateau; Item Number: 15-0027/11;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1521-2026More 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 screw recalled for detaching bushing
- FDA-Device2026-03-18Waldemar Link Endo-Model SL Connection Component recalled for potential bushing detachment
- FDA-Device2026-03-18Waldemar Link Endo-Model Replacement Plateau screw recalled for potential bushing detachment
Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief