Waldemar Link Endo-Model Replacement Plateau screw recalled for detaching bushing
Waldemar Link's Endo-Model Replacement Plateau screws (Item 15-8030/12) may have a bushing that can detach from the screw shaft due to a crack in the screw. This could affect the stability of knee replacement implants. Four units have been identified in this recall, primarily distributed outside the United States.
From the FDA notice · Read the official notice ↗ · All Waldemar Link recalls
What to do
- Contact your surgeon or orthopedic clinic if you received this implant
- Report the product serial/lot number from your implant records (250721/0194, 0212, 0211, or 0209)
- Follow your healthcare provider's guidance on whether removal or replacement is needed
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Endo-Model Replacement Plateau; Item Number: 15-8030/12;
- Sold in
- Nationwide
- Made for
- Adults (18 years to 100 years)
This recall covers 13 products — see all of them.
Details
- Units affected
- 4 units (all OUS)
- Illnesses reported
- None reported
- Manufactured in
- Ost Str. 4-10, N/A, Norderstedt, N/A, Germany
- Classification
- Class II
- Recall number
- Z-1517-2026
In the FDA's words
- Description
- Endo-Model Replacement Plateau; Item Number: 15-8030/12; 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: 15-8030/12; UDI-DI: 04026575048151; Serial/Lot Number: 250721/0194, 250721/0212, 250721/0211, 250721/0209; 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: 4 units (all OUS)
- 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; (this page)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;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