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)
FDA Recall Z-0478-2008 · Posted 2008-01-26
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Recalling FirmBlackstone Medical, Inc.
Recall StatusTerminated
Product CodeKWQ
Date Initiated2006-05-08
Date Terminated2008-11-06
Product Quantity1,991 semi-constrained primary and rescue screws.
Reason for Recall
Incomplete Design Validation: the laser marking on the head of the screw lacked complete process qualification
Firm 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.
Root Cause
Device Design
Distribution Pattern
Nationwide
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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