Recall Z-1943-2010
Biomet Microfixation, Inc. · initiated October 5, 2009
Product
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.
Codes / lots: Lot 829760
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.
FDA-determined 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.
Details
- Recall number
- Z-1943-2010
- Initiated
- October 5, 2009
- Posted by FDA
- June 30, 2010
- Terminated
- December 15, 2010
- Product code
- JEY – Plate, Bone
- Quantity
- 91 units
- Distribution
- US distribution: CA, CO, MI, and MO.
- Recalling firm
- Biomet Microfixation, Inc., Jacksonville, FL