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.
This recall has been terminated (originally issued May 19, 2010).
- Company
- Blackstone Medical, Inc.
- Recall Initiated
- April 21, 2010
- Posted
- May 19, 2010
- Terminated
- August 10, 2010
- Recall Number
- Z-1613-2010
- Quantity
- 92
- Firm Location
- Wayne, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Nationwide and to one location each in Australia and Spain.
Lot / Code Info
Part Number 52-1026; Lot numbers16380-xxxx and 17162-xxxx
Root Cause
Nonconforming Material/Component
Action Taken
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.