Recall Z-0975-2013 ยท HTW Bit, Drill
Orthohelix Surgical Designs Inc
Intraosseous Fixation System (IFS) 1.7 mm, 2.0 mm & 2.5 mm Cannulated Drill Bit. Intended to stabilize and aid in fixation of fractures.
| Date | Mar 22, 2013 (initiated Oct 30, 2012) |
| Status | Terminated |
| Reason | The firm was notified by a customer that there was a burr on the inside end of the drill bit resulting in the drill bit not fitting over the associated guide wire. |
| Root cause | Nonconforming Material/Component |
| Action | OrthoHelix sent a "FIELD REMOVAL NOTIFICATION" letter dated November 7, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at 330-247-1444 for questions concerning this notice. |
| Quantity | Lot # 2399041, 97 pcs; Lot # 2399051, 143 pcs; Lot # 2399051R, 4 pcs & Lot # 2399061, 119 pcs |
| Distribution | Nationwide Distribution including the states of CA, CO, IL, MI, MD, NC, NM, OH, OK, PA, SD, TX, UT, VA, WA and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.