FDA Medical Device Recalls (openFDA)
Blackstone Medical, Inc.: Blackstone Medical Inc./ Orthofix Spinal Implants, Hallmark Anterior Cervical Plate System; Plate Bender Part number 62-0070. Non Sterile.
- Recall number
- Z-1653-2010
- 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.
- Status
- Terminated
- Initiated
- 2010-03-15
- Posted
- 2010-05-26
- Terminated
- 2011-09-09
- Reason
- 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
- 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
- 98 units domestically, 14 units internationally.
- Distribution
- Nationwide distribution, including Puerto Rico, and to Australia.
- Lot, serial or model codes
- Part number 62-0070, all lots.
- 510(k) numbers
- ["K050892"]
- PMA numbers
- not on file
- Product code
- KWQ
- Firm FEI
- 3001238051
- Firm city
- Wayne
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28