FDA recall Z-2641-2023
Waldemar Link GmbH & Co. KG (Mfg Site) · Class II · device
Product
MobileLink Acetabular Cup System, Shell/Insert Adapter for Shell 74-80mm, Insert Size F, +12mm Offset 20 degrees Inclination
Reason for recall
Product is labeled with incorrect offset.
Distribution
Domestic distribution to AL, NJ, NV.
Key facts
- Status
- Ongoing
- Initiation date
- 2023-07-14
- Report date
- 2023-10-04
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Norderstedt, N/A, Germany
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2641-2023