FDA Device recall Z-1869-2013
Caddy - PedFuse, Screw Caddy, 8MM and 9MM, Part Number: 11-80009 Rev
- FDA Device
- Class II
- terminated
- Published 2013-08-07
On 2013-08-07 the FDA classified a Class II recall of Caddy - PedFuse, Screw Caddy, 8MM and 9MM, Part Number: 11-80009 Rev by Spinefrontier, citing two sections that are designated for the 8mm and 9mm screws were switched; the holes that hold the 8mm screws are designed for 9mm screws, and the holes that hold the 9mm screws a….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1869-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-10-05 |
| Published | 2013-08-07 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Spinefrontier |
| Distribution | CO, DC, MA, TX |
Product
Caddy - PedFuse, Screw Caddy, 8MM and 9MM, Part Number: 11-80009 Rev. B The caddy holds, in an organized fashion within the case, 8mm and 9mm pedicle screws used during implantation of pedicle screw system devices intended to provide immobilization and stabilization of spinal segments of skeletally mature patients
Reason
Two sections that are designated for the 8mm and 9mm screws were switched; the holes that hold the 8mm screws are designed for 9mm screws, and the holes that hold the 9mm screws are designated for 8mm screws.
Identifiers
| code_info | 31176, 018652, 018645R, 42011 |
|---|
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-1869-2013%22
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