PROFEMUR(R) MODULAR NECK, HIP FEMORAL NECK MicroPort total hip systems intended for use in total hip arthroplasty for re
FDA device recall Z-2588-2016 · posted 2016-08-18 · Terminated
Recall details
- Recalling firm
- MicroPort Orthopedics Inc.
- Reason for recall
- Profemur(R) neck, Item Number PHA01222 (Short AR VV2 Ti Neck) was labeled as Item Number PHA01212 (Short AR VV1 Ti Neck).
- Action taken
- The firm initiated their recall by email on 06/30/2016.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- LWJ
- Quantity affected
- 14 units
- Distribution
- Belgium, Italy, Spain, and Poland
- Date initiated
- 2016-06-30
- Date posted
- 2016-08-18
- Date terminated
- 2017-01-21
- Location
- Arlington, TN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PRO-FEMUR R (K003016) | Wrightmedicaltechnologyinc | 2000-12-13 |