Alphatec Spine, Inc., NOVEL SPINAL SPACER SYSTEM, Part Number(s): 64817-010, 64817-012, 64817-013, 64817-014, 64817-107,
FDA device recall Z-0190-2010 · posted 2009-11-12 · Terminated
Recall details
- Recalling firm
- Alphatec Spine, Inc.
- Reason for recall
- Due to a deficiency in the process validation related to the machine that manufactured these parts, Alphatec would like to have the parts returned to them so that they may perform an additional inspection of each implant.
- Action taken
- Alphatec Spine notified consignees of the affected product via telephone. The firm requested that consignees immediately remove the affected devices in their possession and return to Alphatec Spine. For further information, contact Alphatec Spine at 1-800-922-1356.
- Root cause
- Process control
- Status
- Terminated
- Product code
- MAX
- Quantity affected
- 37 devices
- Distribution
- Nationwide Distribution -- CA, NV, FL, CT, TX, IA and WI.
- Date initiated
- 2009-05-13
- Date posted
- 2009-11-12
- Date terminated
- 2009-11-13
- Location
- Carlsbad, CA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NOVEL SPINAL SPACER SYSTEM (K080699) | Alphatec Spine, Inc. | 2008-05-21 |