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
FDA device recall Z-1430-2010 · posted 2010-04-22 · Terminated
Recall details
- Recalling firm
- Orthohelix Surgical Designs Inc
- Reason for recall
- The epoxy is flaking off the drill bits and countersinks.
- Action taken
- 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
- Status
- Terminated
- Product code
- HTW
- Quantity affected
- 74 pieces
- Distribution
- Nationwide Distribution -- CO, OH, PA, SD, TX & VA.
- Date initiated
- 2009-09-03
- Date posted
- 2010-04-22
- Date terminated
- 2012-02-28
- Location
- Medina, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MAXTORQUE MINI CANNULATED SCREW SYSTEM (K082574) | Orthohelix Surgical Designs, Inc. | 2008-12-08 |