FDA Medical Device Recalls (openFDA)
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 number
- Z-1430-2010
- Recalling firm
- Orthohelix Surgical Designs 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
- Status
- Terminated
- Initiated
- 2009-09-03
- Posted
- 2010-04-22
- Terminated
- 2012-02-28
- Reason
- The epoxy is flaking off the drill bits and countersinks.
- 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
- 74 pieces
- Distribution
- Nationwide Distribution -- CO, OH, PA, SD, TX & VA.
- Lot, serial or model codes
- Lot NG808, Lot NG861, & Lot 1048031.
- 510(k) numbers
- ["K082574"]
- PMA numbers
- not on file
- Product code
- HTW
- Firm FEI
- 3000718467
- Firm city
- Medina
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28