Intraosseous Fixation System — Class II medical device recall Z-0975-2013
Terminated recall by Orthohelix Surgical Designs Inc, reported 2013-04-03, distributed nationwide. The firm was notified by a customer that there was a burr on the inside end of the drill bit resulting in the
| Recall number | Z-0975-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Orthohelix Surgical Designs Inc, Medina, OH, United States |
| Recall initiated | 2012-10-30 |
| Classified | 2013-03-22 |
| Reported by FDA | 2013-04-03 |
| Terminated | 2013-12-05 |
| Distributed | Nationwide (US) |
| Lot numbers | 2399041, 2399051, 2399051R, 2399061 |
| Model numbers | IFS-072-17-C, IFS-072-25-C, IFS-72-20-C |
Product
Intraosseous Fixation System (IFS) 1.7 mm, 2.0 mm & 2.5 mm Cannulated Drill Bit. Intended to stabilize and aid in fixation of fractures.
Reason for recall
The firm was notified by a customer that there was a burr on the inside end of the drill bit resulting in the drill bit not fitting over the associated guide wire.
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-0975-2013. 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.