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.
This recall has been terminated (originally issued June 30, 2010).
- Company
- Biomet Microfixation, Inc.
- Recall Initiated
- October 5, 2009
- Posted
- June 30, 2010
- Terminated
- December 15, 2010
- Recall Number
- Z-1943-2010
- Quantity
- 91 units
- Firm Location
- Jacksonville, FL
- Official Source
- View on FDA website ↗
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.
Distribution
US distribution: CA, CO, MI, and MO.
Lot / Code Info
Lot 829760
Root Cause
Process design
Action Taken
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.
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