FDA-Device2026-03-18Class IIPROCESSING DEFECT
Waldemar Link Endo-Model Replacement Plateau recalled for potential bushing detachment
What this means
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
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
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-1521-2026Want us to check the next one for you?
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