BIOMET MICROFIXATION REF: 91-6103 "1.5MM" SYSTEM HIGH TORQUE (HT), SD, X-DR, SCREW 1.5MM X 3.5MM (WXL) TITANIUM LOT 829760, ***NON STERILE PRODUCT***. Bone screws used along with implantable bone plates for oral, cranio-maxillofacial procedures.
FDA Recall Z-1943-2010 · Posted 2010-06-30
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Recalling FirmBiomet Microfixation, Inc.
Recall StatusTerminated
Product CodeJEY
Date Initiated2009-10-05
Date Terminated2010-12-15
Product Quantity91 units
Reason for Recall
Biomet Microfixation is recalling 91-6103 1.5x3.5mm HT SD X-drive screw Lot Number 829760. This package may contain 91-6704 1.5x4mm ThinFlap SD X-drive screw.
Firm Action
Biomet Microfixation notified each consignee by email and fax on 10/05/2009. Each consignee was asked to use the included Response Form to provide product disposition.
Root Cause
Process design
Distribution Pattern
US distribution: CA, CO, MI, and MO.
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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