Waldemar Link GmbH & Co. KG (Mfg Site): Endo-Model Replacement Plateau; Item Number: 15-8521/15;
Read the official notice at FDA (device) →
Get alerts for Waldemar Link GmbH & Co. KG
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Product
- Endo-Model Replacement Plateau; Item Number: 15-8521/15;
- Reason / hazard
- The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- 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.
- Recall initiated
- 2026-01-12
- Code info
- Item Number: 15-8521/15; UDI-DI: 04026575383283; Serial/Lot Number: 250805/0020, 250805/0021, 250805/0023, 250805/0024;
- Product quantity
- 4 units (OUS only)
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Norderstedt
- State
- N/A
- Country
- Germany
- Event id
- 98342
Free daily digest + "My products" watchlist