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.
Recall
- Recall Number
- Z-1613-2010
- Event Number
- 55508
- Firm
- Blackstone Medical, Inc.
- FEI Number
- 3001238051
- Product Code
- HWX
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- April 21, 2010
- Posted
- May 19, 2010
- Terminated
- August 10, 2010
- Address
- 1211 Hamburg Tpke, Suite 300, Wayne, NJ, 07470
Description
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.
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.
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.
Nationwide and to one location each in Australia and Spain.
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