Z-0478-2008

Hallmark Anterior Cervical Plate System: Primary Bone Screw, Semi Constrained, REF # 62-3140,14mm; Blackstone...

Name: Z-0478-2008 Hallmark Anterior Cervical Plate System: Primary Bone Screw, Semi Constrained, REF # 62-3140,14mm; Blackstone...
Creator: Blackstone Medical, Inc.
Published: 2006-05-08
License: https://open.fda.gov/license/

Blackstone Medical, Inc. / initiated 2006-05-08 / Terminated / root cause: design

FDA source

Blackstone Medical, Inc. began a recall of Hallmark Anterior Cervical Plate System: Primary Bone Screw, Semi Constrained, REF # 62-3140,14mm; Blackstone Medical, 90 Brookdale Drive, Springfield, MA... on 2006-05-08. The reason FDA records is "Incomplete Design Validation: the laser marking on the head of the screw lacked complete process qualification". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0478-2008
Status: Terminated
Initiated: 2006-05-08
Posted: 2008-01-26
Terminated: 2008-11-06
Recalling firm: Blackstone Medical, Inc.
Product: Hallmark Anterior Cervical Plate System: Primary Bone Screw, Semi Constrained, REF # 62-3140,14mm; Blackstone Medical, 90 Brookdale Drive, Springfield, MA 01104 (The Hallmark Anterior Cervical Plate Systems consists of an assortment of implantable titanium alloy plates and bone screws that are provided non-sterile)
Product code: KWQ Appliance, Fixation, Spinal Intervertebral Body
Reason for recall: Incomplete Design Validation: the laser marking on the head of the screw lacked complete process qualification
Root cause tag: design
FDA root cause: Device Design
Action: On May 8, 2006, a communication to the field was sent via phone, e-mail and fax. Instruction was made to retrieve and return all product in the field.
Quantity in commerce: 1,991 semi-constrained primary and rescue screws.
Distribution: Nationwide
Product codes and lots: All Lots (Primary semi-contained rescue Screws: P/N's 62-3100 through 62-3180 and rescue simi-constrained bone screws P/N's 62-4100- 62-4180)

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)