Recall Z-1943-2010 ยท JEY Plate, Bone
Biomet Microfixation, Inc.
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.
| Date | Jun 30, 2010 (initiated Oct 5, 2009) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process design |
| 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. |
| Quantity | 91 units |
| Distribution | US distribution: CA, CO, MI, and MO. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K953385 | LORENZ 1.0MM, 1.5MM, 2.0MM SYSTEM Walter Lorenz Surgical, Inc., Sep 28, 1995 |