Blackstone Medical, Inc. 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) Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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)
Brand
Blackstone Medical, Inc.
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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)
Blackstone Medical, Inc. is recalling Hallmark Anterior Cervical Plate System: Primary Bone Screw, Semi Constrained, REF # 62-3140,14mm; B due to Incomplete Design Validation: the laser marking on the head of the screw lacked complete process qualification. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Incomplete Design Validation: the laser marking on the head of the screw lacked complete process qualification
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026