Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0026-2013 — OrthoHelix Part #HCS-056-32 3.2MM 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, a

U.S. FDA — Device Enforcement · United States · 2010-01-29 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0026-2013
Date of alert: 2010-01-29
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Orthohelix Surgical Designs Inc
Product category: device
Product type: Devices

Reported risk: The tips of the drivers are breaking while being used to drive the screws into patients.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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