Z-2517-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 1, 2018
- Initiation Date
- December 28, 2017
- Termination Date
- September 1, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 304, 3 in US
Product Description
2M insert 15degree for MUTARS RS cup and LUMiC TiN orthopedic hip implant acetabular component. Size 38/39 mm REF number 02423839 Size 42/44 mm REF number 02424244 Size 44/48 mm REF number 02424448 Size 46/52 mm REF number 02424652
Reason for Recall
Possibility that the retaining ring in the 2M inlay 15degree for MUTARS RS Cup and LUMiC TiN is incorrectly mounted.
Distribution Pattern
Distribution in Europe and US states of Texas, Rhode Island and Georgia.
Code Information
Article/Batch numbers: Size 38/39 mm REF number 02423839 Batch 150201G, 1504298, 1504299, 150429C, 150429L; Size 42/44 mm REF number 02424244 Batch 1702188, 15042AF, 15042A7, 15042A6, 15042A5; Size 44/48 mm REF number 02424448 Batch 1702189, 1637108, 16141C1; Size 46/52 mm REF number 02424652 Batch 1637109, 16141C2.