Arsenal Spinal Fixation System, Set Screw, Part No. 47127 Product Usage: Usage: The Arsenal Spinal Fixation System is in
FDA device recall Z-0592-2017 · posted 2016-11-16 · Terminated
Recall details
- Recalling firm
- Alphatec Spine, Inc.
- Reason for recall
- Alphatec Spine is recalling the Arsenal Spinal Fixation System Set Screw due to a trend in set screw postoperative disengagement from the screw body.
- Action taken
- Alphatae Spine sent an Urgent Medical Device Recall notification letter dated September 29, 2016 to customers. The letter identified the affected product, problem and the actions to be taken. Customers are instructed to fill out and return the last page of recall letter using one of the methods identified in the letter.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- NKB
- Quantity affected
- 16,972 units
- Distribution
- Worldwide Distribution - US Nationwide in the countries of Japan, UK, NSW, Spain.
- Date initiated
- 2016-10-05
- Date posted
- 2016-11-16
- Date terminated
- 2017-02-17
- Location
- Carlsbad, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ARSENAL SPINAL FIXATION SYSTEM (K133221) | Alphatec Spine, Inc. | 2014-03-13 |