Device product
PROFEMUR(R) MODULAR NECK, HIP FEMORAL NECK MicroPort total hip systems intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.
Z-2588-2016
Product summary
- Event
- Event 74752
- Status
- Terminated
- Classification
- Class II
- Quantity
- 14 units
- Official record key
device-enforcement:Z-2588-2016
Official wording
Reason: Profemur(R) neck, Item Number PHA01222 (Short AR VV2 Ti Neck) was labeled as Item Number PHA01212 (Short AR VV1 Ti Neck).
Code information: Lot number 1645222
Distribution pattern: Belgium, Italy, Spain, and Poland
Derived failure modes
-
Unknown
Profemur(R) neck, Item Number PHA01222 (Short AR VV2 Ti Neck) was labeled as Item Number PHA01212 (Short AR VV1 Ti Neck).