Z-1653-2010

Blackstone Medical Inc./ Orthofix Spinal Implants, Hallmark Anterior Cervical Plate System; Plate Bender Part...

Name: Z-1653-2010 Blackstone Medical Inc./ Orthofix Spinal Implants, Hallmark Anterior Cervical Plate System; Plate Bender Part...
Creator: Blackstone Medical, Inc.
Published: 2010-03-15
License: https://open.fda.gov/license/

Blackstone Medical, Inc. / initiated 2010-03-15 / Terminated / root cause: manufacturing process

FDA source

Blackstone Medical, Inc. began a recall of Blackstone Medical Inc./ Orthofix Spinal Implants, Hallmark Anterior Cervical Plate System; Plate Bender Part number 62-0070. Non Sterile on 2010-03-15. The reason FDA records is "The Hallmark Anterior Cervical Plate Bender may have a non conformity causing difficulty accepting 3-4 level plates or to not accept 3-4 level plates that are intended to be additionally contoured". 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-1653-2010
Status: Terminated
Initiated: 2010-03-15
Posted: 2010-05-26
Terminated: 2011-09-09
Recalling firm: Blackstone Medical, Inc.
Product: Blackstone Medical Inc./ Orthofix Spinal Implants, Hallmark Anterior Cervical Plate System; Plate Bender Part number 62-0070. Non Sterile.
Product code: KWQ Appliance, Fixation, Spinal Intervertebral Body
Reason for recall: The Hallmark Anterior Cervical Plate Bender may have a non conformity causing difficulty accepting 3-4 level plates or to not accept 3-4 level plates that are intended to be additionally contoured.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Orthofix send letters of notification of planned product removal to distributors who keep the instrumentation set on 3/29/2010 by Fed Ex. Letters of planned product removal explain the reason for the planned removal and the specific product involved. Replacement product will not be available until July 2010, however, the firm elected to notify customers of the potential problem and the date that formal notification and replacement Plate Benders will be available. Letters state that if there is any problem with the Plate Benders, questions can be directed to David Thompson in Marketing at 972-529-3024 or Jose Charvet in Product Development at 973-406-2824.
Quantity in commerce: 98 units domestically, 14 units internationally.
Distribution: Nationwide distribution, including Puerto Rico, and to Australia.
Product codes and lots: Part number 62-0070, all lots.

Product code KWQ

K050892Class IIHallmarktm Anterior Cervical Plate SystemBlackstone Medical, Inc. / cleared 2005-05-11

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)