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Terminated

Mini Max Torque 2.6 mm diameter Drill Bit, Model #HCS-072-26 & 3.8 mm Countersink, Model # HCS-070-38. Used to drill or cut bone prior to implantation of screws

FDA Recall Z-1430-2010 · Posted 2010-04-22

Recalling FirmOrthohelix Surgical Designs Inc
Recall StatusTerminated
Product CodeHTW
Date Initiated2009-09-03
Date Terminated2012-02-28
Product Quantity74 pieces

Reason for Recall

The epoxy is flaking off the drill bits and countersinks.

Firm Action

On 9/3/2009 the firm sent letters to their customers requesting return of all recalled product in stock and for those products to be replaced with the ones listed in the letter. Questions should be directed to 330-869-0625.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Nationwide Distribution -- CO, OH, PA, SD, TX & VA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K082574MAXTORQUE MINI CANNULATED SCREW SYSTEMOrthohelix Surgical Designs, Inc. · 2008-12-08

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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