FDA recall Z-1522-2026

Waldemar Link GmbH & Co. KG (Mfg Site) · Class II · device

Product

Endo-Model Replacement Plateau; Item Number: 15-0027/12;

Reason for recall

The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

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.

Key facts

Status
Ongoing
Initiation date
2026-01-12
Report date
2026-03-18
Voluntary/Mandated
Voluntary: Firm initiated
Location
Norderstedt, N/A, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1522-2026