Apex ARC Hip Stem, HA Coated, Size 5; Product Code: HC-21005-HA Product Usage: The Apex ARC Hip Stem is the femoral comp
FDA device recall Z-2064-2015 · posted 2015-07-14 · Terminated
Recall details
- Recalling firm
- Omnilife Science Inc.
- Reason for recall
- Product may breach the inner and outer sterile pouches during shipping or handling.
- Action taken
- All product is consigned to US Agents until implanted or returned to OMNI. All US Agents holding the potentially affected inventory were notified that the product is being recalled via letter on June 3, 2015. The letter instructs them to immediately discontinue use of the product and contact OMNI Customer Service at 800-448-6664 to request a return materials authorization, and to return the Acknowledgement and Receipt form by FAX to 508-819-3390 or email to cflores@omnils.com.
- Root cause
- Packaging
- Status
- Terminated
- Product code
- LZO
- Quantity affected
- 146 devices
- Distribution
- US Nationwide Distribution in the states of: UT, CA, FL, TX, MA, GA, OK, VA, CT, OK, and WY.
- Date initiated
- 2015-06-03
- Date posted
- 2015-07-14
- Date terminated
- 2015-09-08
- 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 |