LineSider Spinal System pedicle screws, 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-cannulated. Model Number LS-N
FDA device recall Z-0421-2023 · posted 2022-12-05 · Terminated
Recall details
- Recalling firm
- Integrity Implants Inc.
- Reason for recall
- Potential for intraoperative screw head separation at weld location.
- Action taken
- Integrity Implants notified consignees on about 08/03/2022 via emailed letter. The letter instructed consignees to examine inventory and quarantine any affected product, arrange for the return of affected products, and complete and return the response form.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- NKB
- Quantity affected
- 50 screws
- Distribution
- US distribution to California, Indiana, New York, Oklahoma, Washington DC
- Date initiated
- 2022-08-03
- Date posted
- 2022-12-05
- Date terminated
- 2023-10-23
- Location
- Palm Beach Gardens, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LineSiderâ„¢ Spinal System (K203367) | Integrity Implants, Inc. | 2020-12-03 |