8.5MM Bone Tap, Modular; Manufactured by: Blackstone Medical, Inc. 1720 Bray Central Drive, McKinney, TX 75069. Intended
FDA device recall Z-1615-2010 · posted 2010-05-19 · Terminated
Recall details
- Recalling firm
- Blackstone Medical, Inc.
- 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.
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- HWX
- Quantity affected
- 95
- Distribution
- Nationwide and to one location each in Australia and Spain.
- Date initiated
- 2010-04-21
- Date posted
- 2010-05-19
- Date terminated
- 2010-08-10
- Location
- Wayne, NJ
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