Orthohelix Surgical Designs Inc 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Orthohelix Surgical Designs Inc
Lot Codes / Batch Numbers
Lot NG808, Lot NG861, & Lot 1048031.
Products Sold
Lot NG808, Lot NG861, & Lot 1048031.
Orthohelix Surgical Designs Inc is recalling Mini Max Torque 2.6 mm diameter Drill Bit, Model #HCS-072-26 & 3.8 mm Countersink, Model # HCS-070-3 due to The epoxy is flaking off the drill bits and countersinks.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The epoxy is flaking off the drill bits and countersinks.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026