Waldemar Link Endo-Model Replacement Plateau screw recalled for potential bushing detachment
Waldemar Link GmbH & Co. KG is recalling certain Endo-Model Replacement Plateau screws (Item Number 15-8521/11) because the bushing could detach from the screw shaft due to a crack. This could affect the function of the implant. No injuries have been reported.
From the FDA notice · Read the official notice ↗ · All Waldemar Link recalls
What to do
- If you received this implant, contact your surgeon or healthcare provider immediately.
- Provide your healthcare provider with the item number (15-8521/11) and the lot numbers listed in this recall.
- Do not use or implant any units from the affected lot numbers: 250728/2220, 250728/2222, 250728/2223, 250728/2224, 250728/2225, 250728/2226, 250728/2227.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Endo-Model Replacement Plateau; Item Number: 15-8521/11;
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
This recall covers 13 products — see all of them.
Details
- Units affected
- 7 units (OUS only)
- Illnesses reported
- None reported
- Manufactured in
- Ost Str. 4-10, N/A, Norderstedt, N/A, Germany
- Classification
- Class II
- Recall number
- Z-1519-2026
In the FDA's words
- Description
- Endo-Model Replacement Plateau; Item Number: 15-8521/11; The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. Item Number: 15-8521/11; UDI-DI: 04026575383245; Serial/Lot Number: 250728/2220, 250728/2222, 250728/2223, 250728/2224, 250728/2225, 250728/2226, 250728/2227; Distribution: 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 quantity: 7 units (OUS only)
- Hazard
- The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
13 products in this recall
Waldemar Link Endo-Model implant parts recalled for fracture risk
Waldemar Link is recalling 13 Endo-Model implant components, including replacement plateaus and connection components with PE-Plateau. The bushing on these implants could detach from the screw shaft because of a longitudinal fracture. No injuries have been reported.
The agency lists each product separately. Check every one you might have.
- Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/05;Z-1511-2026 · 44 units (1 US, 43 OUS)
- Endo-Model Replacement Plateau; Item Number: 15-0027/15;Z-1512-2026 · 3 units
- Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/02;Z-1513-2026 · 49 units (OUS only)
- Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07;Z-1514-2026 · 31 units (OUS only)
- Endo-Model Replacement Plateau; Item Number: 15-2835/12;Z-1515-2026 · 1 unit (OUS only)
- Endo-Model Replacement Plateau; Item Number: 15-2836/11;Z-1516-2026 · 7 units (OUS only)
- Endo-Model Replacement Plateau; Item Number: 15-8030/12;Z-1517-2026 · 4 units (all OUS)
- Endo-Model Replacement Plateau; Item Number: 15-8521/09;Z-1518-2026 · 8 units (OUS only)
- Endo-Model Replacement Plateau; Item Number: 15-8521/11; (this page)Z-1519-2026 · 7 units (OUS only)
- Endo-Model Replacement Plateau; Item Number: 15-8521/15;Z-1520-2026 · 4 units (OUS only)
- Endo-Model Replacement Plateau; Item Number: 15-0027/11;Z-1521-2026 · 2 units (OUS only)
- Endo-Model Replacement Plateau; Item Number: 15-0027/12;Z-1522-2026 · 1 unit (OUS only)
- Endo-Model Replacement Plateau; Item Number: 15-0027/16;Z-1523-2026 · 3 units (OUS only)
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ModerateFDAAug 19, 2026