FDA Medical devices recall ·
Endo-Model Replacement Plateau recall
- Recall number
- Z-1519-2026
- Date
- (initiated January 12, 2026)
- Company / brand
- Waldemar Link GmbH & Co. KG (Mfg Site)
Ost Str. 4-10, Norderstedt, N/A, Germany - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 7 units (OUS only)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Endo-Model Replacement Plateau; Item Number: 15-8521/11;
Why was it recalled?
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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.
States: New Jersey
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1519-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.