Leucadia Autolok" Polyaxial Pedicle Screw System. Intended to help provide correction, immobilization and stabilization
FDA device recall Z-1421-2013 · posted 2013-05-28 · Terminated
Recall details
- Recalling firm
- Alphatec Spine, Inc.
- Reason for recall
- Alphatec Spine initiated this medical device recall for the following reason: due to tolerancing, the flange of the Phygen Leucadia" Autolok set screw may interfere with the top of the screw head prior to fully locking the rod. If this condition occurs, the polyaxial screw head and rod may fail to provide a rigid construct under loading. To date there have been no reports of patient injury, adve
- Action taken
- Alphatec Spine initiated recall by contacting customers via telephone and/or email on 05/06/2013. An Urgent Medical Device Recall Notification letter along with a response form were sent via FedEx to all affected accounts. The letter identified the product, problem, and actions to be taken by the customers.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- NKB
- Quantity affected
- 1,814
- Distribution
- Nationwide Distribution.
- Date initiated
- 2013-05-06
- Date posted
- 2013-05-28
- Date terminated
- 2014-09-25
- Location
- Carlsbad, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LEUCADIA AUTOLOK PEDICLE SCREW SYSTEM (K113366) | Phygen, LLC | 2012-01-17 |