Recall Z-2588-2016 ยท LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
MicroPort Orthopedics Inc.
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.
| Date | Aug 18, 2016 (initiated Jun 30, 2016) |
| Status | Terminated |
| Reason | Profemur(R) neck, Item Number PHA01222 (Short AR VV2 Ti Neck) was labeled as Item Number PHA01212 (Short AR VV1 Ti Neck). |
| Root cause | Error in labeling |
| Action | The firm initiated their recall by email on 06/30/2016. |
| Quantity | 14 units |
| Distribution | Belgium, Italy, Spain, and Poland |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K003016 | PRO-FEMUR R Wrightmedicaltechnologyinc, Dec 13, 2000 |