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Terminated

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.

FDA Recall Z-1613-2010 · Posted 2010-05-19

Recalling FirmBlackstone Medical, Inc.
Recall StatusTerminated
Product CodeHWX
Date Initiated2010-04-21
Date Terminated2010-08-10
Product Quantity92

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.

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Nationwide and to one location each in Australia and Spain.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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