Reported Oct 17, 2012 · Terminated
OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in…
Orthohelix Surgical Designs Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Orthohelix Surgical Designs Inc · 1065 Medina Rd., Suite 500 · Medina, OH · 44256
Is this the product you have?
- OrthoHelix Part #HCS-056-32 3.2MM
- Cannulated Hex Driver NON STERILE MAT465 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
- Lot codes and dates
- HSC-056-32-1067051
- Amount recalled
- 47 Pieces
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
The tips of the drivers are breaking while being used to drive the screws into patients.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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