FDA Recall
Terminated
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
Recall: Z-2517-2018
·
Initiated December 28, 2017
Recall
- Recall Number
- Z-2517-2018
- Event Number
- 80498
- Firm
- IMPLANTCAST GMBH Luneburger Schanze 26 Buxtehude Germany
- FEI Number
- 3012523063
- Product Code
- LZO
- Status
- Terminated
- Root Cause
- Process design
- Initiated
- December 28, 2017
- Terminated
- September 1, 2020
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
Possibility that the retaining ring in the 2M inlay 15degree for MUTARS RS Cup and LUMiC TiN is incorrectly mounted.
Action
Implantcast sent customers an Urgent Product Safety Information / Product Recall letter on December 28, 2017. The letter recommends that physicians follow their patients by radiological exam. There is a return form for the hospital or physician to confirm receipt of the letter.
Distribution
Distribution in Europe and US states of Texas, Rhode Island and Georgia.
Quantity
304, 3 in US