Z-1430-2010

Mini Max Torque 2.6 mm diameter Drill Bit, Model #HCS-072-26 & 3.8 mm Countersink, Model # HCS-070-38. Used...

Name: Z-1430-2010 Mini Max Torque 2.6 mm diameter Drill Bit, Model #HCS-072-26 & 3.8 mm Countersink, Model # HCS-070-38. Used...
Creator: Orthohelix Surgical Designs Inc
Published: 2009-09-03
License: https://open.fda.gov/license/

TORNIER Inc. / initiated 2009-09-03 / Terminated / root cause: manufacturing process

FDA source

Orthohelix Surgical Designs Inc began a recall of 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 on 2009-09-03. The reason FDA records is "The epoxy is flaking off the drill bits and countersinks". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1430-2010
Status: Terminated
Initiated: 2009-09-03
Posted: 2010-04-22
Terminated: 2012-02-28
Recalling firm: TORNIER Inc.
Product: 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
Product code: HTW Bit, Drill
Reason for recall: The epoxy is flaking off the drill bits and countersinks.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
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.
Quantity in commerce: 74 pieces
Distribution: Nationwide Distribution -- CO, OH, PA, SD, TX & VA.
Product codes and lots: Lot NG808, Lot NG861, & Lot 1048031.

Product code HTW

K082574Class IIMaxtorque Mini Cannulated Screw SystemOrthohelix Surgical Designs, Inc. / cleared 2008-12-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)