OrthoHelix Part #HCS-056-32 3 — Class II medical device recall Z-0027-2013
Terminated recall by Orthohelix Surgical Designs Inc, reported 2012-10-17, distributed nationwide. The tips of the drivers are breaking while being used to drive the screws into patients.
| Recall number | Z-0027-2013 |
|---|---|
| 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 | 2010-01-29 |
| Classified | 2012-10-09 |
| Reported by FDA | 2012-10-17 |
| Terminated | 2013-02-20 |
| Distributed | Nationwide (US) |
| Quantity | 120 units |
| Model numbers | 3.8MM, HCS-056-32 |
Product
OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Reason for recall
The tips of the drivers are breaking while being used to drive the screws into patients.
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-0027-2013. 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.