FDA recall Z-2048-2023

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

Product

LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 4, Right

Reason for recall

The firm discovered through customer complaints that device segments may not meet specifications.

Distribution

Domestic: AL, GA, IL, IN, KS, NJ, NY, and TX. Foreign: Argentina, Australia, Austria, Brazil, Finland, France, Germany, India, Italy, Spain, and United Kingdom.

Key facts

Status: Ongoing
Initiation date: 2021-03-18
Report date: 2023-07-05
Voluntary/Mandated: Voluntary: Firm initiated
Location: Norderstedt, N/A, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2048-2023