Caddy — Class II medical device recall Z-1869-2013
Terminated recall by SpineFrontier, Inc., reported 2013-08-07, distributed in CO, DC, MA, TX. Two sections that are designated for the 8mm and 9mm screws were switched; the holes that hold the 8mm screws
| Recall number | Z-1869-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SpineFrontier, Inc., Beverly, MA, United States |
| Recall initiated | 2012-10-05 |
| Classified | 2013-08-01 |
| Reported by FDA | 2013-08-07 |
| Terminated | 2015-07-29 |
| Distributed | CO, DC, MA, TX |
| Quantity | 11 caddies |
| Model numbers | 11-80009 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1869-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.