TI Standard Polyaxial Screw Assembly 6.5MM x 55MM. Part # 62065-55. Subsequent Product Codes: MNH, MNI. The Zodiac Polya
FDA device recall Z-0269-2013 · posted 2012-11-08 · Terminated
Recall details
- Recalling firm
- Alphatec Spine, Inc.
- Reason for recall
- The recall was initiated because Alphatec Spine confirmed that the TI Standard Polyaxial Screw Assembly was laser marked with the incorrect length of 45 MM.
- Action taken
- Alphatec Spine distributors who received the TI Standard Polyaxial Screw Assembly were contacted by phone and by email on December 9, 2010. A phone script was used as a recall notification to contact their three distributors who received the recalled products. The recall notification informed the customers of the problem identified and the action to be taken. Customers were informed that they will receive replacements within 2-3 days. Customers with questions were instructed to call (800) 922-1356. For questions regarding this recall call 760-431-9286.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- KWP
- Quantity affected
- 11 units
- Distribution
- Nationwide Distribution including TN, WI, and FL.
- Date initiated
- 2010-12-09
- Date posted
- 2012-11-08
- Date terminated
- 2012-11-09
- Location
- Carlsbad, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ICON POLYAXIAL PEDICLE SCREW SYSTEM (K033090) | Alphatec Mfg., Inc. | 2004-03-26 |