Z-1612-2010

5.5MM Bone Tap, Modular; Manufactured by: Blackstone Medical, Inc. 1720 Bray Central Drive, McKinney, TX...

Name: Z-1612-2010 5.5MM Bone Tap, Modular; Manufactured by: Blackstone Medical, Inc. 1720 Bray Central Drive, McKinney, TX...
Creator: Blackstone Medical, Inc.
Published: 2010-04-21
License: https://open.fda.gov/license/

Blackstone Medical, Inc. / initiated 2010-04-21 / Terminated / root cause: manufacturing process

FDA source

Blackstone Medical, Inc. began a recall of 5.5MM Bone Tap, Modular; Manufactured by: Blackstone Medical, Inc. 1720 Bray Central Drive, McKinney, TX 75069. Intended to created a screw thread in a hole... on 2010-04-21. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1612-2010
Status: Terminated
Initiated: 2010-04-21
Posted: 2010-05-19
Terminated: 2010-08-10
Recalling firm: Blackstone Medical, Inc.
Product: 5.5MM 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.
Product code: HWX Tap, Bone
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 94
Distribution: Nationwide and to one location each in Australia and Spain.
Product codes and lots: Part Number 52-1025; Lot numbers16380-xxxx and 17162-xxxx

Product code HWX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)