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)
This recall has been terminated (originally issued January 26, 2008).
- Company
- Blackstone Medical, Inc.
- Recall Initiated
- May 8, 2006
- Posted
- January 26, 2008
- Terminated
- November 6, 2008
- Recall Number
- Z-0478-2008
- Quantity
- 1,991 semi-constrained primary and rescue screws.
- Firm Location
- Wayne, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
Incomplete Design Validation: the laser marking on the head of the screw lacked complete process qualification
Distribution
Nationwide
Lot / Code Info
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)
Root Cause
Device Design
Action Taken
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.
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