LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Cannulated. Thoracolumbosacral pedicle screw syst
FDA device recall Z-0419-2023 · posted 2022-12-05 · Terminated
Recall details
- Recalling firm
- Integrity Implants Inc.
- Reason for recall
- Potential for weld separation of the Upper Tulip Head component from the Lower Tulip Head component, which would result in the separation of the Tulip Head from the Screw Shank.
- Action taken
- Integrity Implants notified consignees on 01/28/2022, via emailed letter. The letter instructed consignees to quarantine affected product, complete and return the Product Tracking & Verification Form, and return affected product. On 02/05/2022 the recall was expanded, and consignees were notified via emailed letter. The listed the additional affected product and contained the same instructions to consignees.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- NKB
- Quantity affected
- 1,702 screws
- Distribution
- Nationwide distribution to AZ, CA, CT, DC, FL, IL, IN, LA, MA, MN, NJ, OK, PR, TN, TX, VA.
- Date initiated
- 2022-01-27
- 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 |