Apex Arc Hip Stem, Size 2, HA Coated; Product Code: HC-21002-HA
FDA device recall Z-2241-2014 · posted 2014-08-15 · Terminated
Recall details
- Recalling firm
- Omnilife Science Inc.
- Reason for recall
- Staining on hip implant.
- Action taken
- All product was consigned to US sales Agents until implanted or returned to OMNI. All US Agents holding the inventory were notified on May9, 2014 by phone and follow up email that the product is being recalled. Customers have been instructed to immediately discontinue use and return the product to OMNIlife science.
- Root cause
- Manufacturing material removal
- Status
- Terminated
- Product code
- LZO
- Quantity affected
- 13 devices
- Distribution
- US: CA, OK, VA, FL, MA, NY, TX
- Date initiated
- 2014-05-09
- Date posted
- 2014-08-15
- Date terminated
- 2014-08-19
- Location
- East Taunton, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| APEX ARC HIP STEM (K090845) | Omni Life Science, Inc. | 2010-04-07 |