ALFA II Modular Femoral Revision Stem Porous Coated; Size 6; Length: 200mm; Diameter:18.0mm; Catalog #651-06-180; compon
FDA device recall Z-1063-2007 · posted 2007-07-23 · Terminated
Recall details
- Recalling firm
- Encore Medical, Lp
- Reason for recall
- Sterility/Package Integrity : Device packaging may potentially be unable to ensure sterility when exposed to shipping conditions.
- Action taken
- Urgent Device Recall Notification letters distributed to consignees on 04/14/07. Consignees requested to return product to Encore Medical, L.P.
- Root cause
- Other
- Status
- Terminated
- Product code
- JDI
- Quantity affected
- 3 units.
- Distribution
- Product distributed to surgical centers in CT, KS and MO.
- Date initiated
- 2007-04-12
- Date posted
- 2007-07-23
- Date terminated
- 2007-07-25
- Location
- Austin, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OMEGA II MODULAR TOTAL HIP SYSTEM (K000817) | Osteoimplant Technology, Inc. | 2000-06-08 |