FDA Device recall Z-1410-2013
50 mm Screw, Item #BG7050 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment
- FDA Device
- Class II
- terminated
- Published 2013-06-05
On 2013-06-05 the FDA classified a Class II recall of 50 mm Screw, Item #BG7050 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment by Spinal Solutions, citing the recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1410-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-02-20 |
| Published | 2013-06-05 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Spinal Solutions |
| Distribution | US |
Product
50 mm Screw, Item #BG7050 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple.
Reason
The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery.
Identifiers
| code_info | Item #BG7050 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1410-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.