Copperhead IBFD — Class II medical device recall Z-1417-2013
Terminated recall by Spinal Solutions, LLC, reported 2013-06-05, distributed nationwide. The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solu
| Recall number | Z-1417-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Spinal Solutions, LLC, Murrieta, CA, United States |
| Recall initiated | 2013-02-20 |
| Classified | 2013-05-27 |
| Reported by FDA | 2013-06-05 |
| Terminated | 2014-03-26 |
| Distributed | Nationwide (US) |
| Quantity | 24 units |
| Model numbers | C5006, C5007, C5008, C5009, C5010, C5011 |
Product
Copperhead IBFD, Large Neutral, 6mm Copperhead IBFD, Large Neutral, 7mm Copperhead IBFD, Large Neutral, 8mm Copperhead IBFD, Large Neutral, 9mm Copperhead IBFD, Large Neutral, 10mm Copperhead IBFD, Large Neutral, 11mm 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 for recall
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.
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-1417-2013. 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.