Recall Z-1613-2010 ยท HWX Tap, Bone
Blackstone Medical, Inc.
6.5MM Bone Tap, Modular; Manufactured by: Blackstone Medical, Inc. 1720 Bray Central Drive, McKinney, TX 75069. Intended to created a screw thread in a hole drilled into bone to facilitate placement of a bone screw.
| Date | May 19, 2010 (initiated Apr 21, 2010) |
| Status | Terminated |
| Reason | Certain lots of the non-cannulated Modular Bone Taps used with the Firebird Spinal Fixation Systems may contain a manufacturing non conformance resulting in the taps creating a single lead screw thread rather than the required dual lead screw thread. |
| Root cause | Nonconforming Material/Component |
| Action | Orthofix issued an "Urgent Product Recall" notification dated April 21, 2010 by USPS certified mail to hospitals and distributors. Consignees were asked to return all affected product to the firm. For additional information, contact the Orthofix Regulatory Affairs Department at 1-973-406-2847. |
| Quantity | 92 |
| Distribution | Nationwide and to one location each in Australia and Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.