Blackstone Medical Inc./ Orthofix Spinal Implants, Hallmark Anterior Cervical Plate System; Plate Bender Part number 62-0070. Non Sterile.
This recall has been terminated (originally issued May 26, 2010).
- Company
- Blackstone Medical, Inc.
- Recall Initiated
- March 15, 2010
- Posted
- May 26, 2010
- Terminated
- September 9, 2011
- Recall Number
- Z-1653-2010
- Quantity
- 98 units domestically, 14 units internationally.
- Firm Location
- Wayne, NJ
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide distribution, including Puerto Rico, and to Australia.
Lot / Code Info
Part number 62-0070, all lots.
Root Cause
Nonconforming Material/Component
Action Taken
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.