BIOMET MICROFIXATION REF: 91-6103 "1.5MM" SYSTEM HIGH TORQUE (HT), SD, X-DR, SCREW 1.5MM X 3.5MM (WXL) TITANIUM LOT 8297
FDA device recall Z-1943-2010 · posted 2010-06-30 · Terminated
Recall details
- Recalling firm
- Biomet Microfixation, Inc.
- 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.
- 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.
- Root cause
- Process design
- Status
- Terminated
- Product code
- JEY
- Quantity affected
- 91 units
- Distribution
- US distribution: CA, CO, MI, and MO.
- Date initiated
- 2009-10-05
- Date posted
- 2010-06-30
- Date terminated
- 2010-12-15
- Location
- Jacksonville, FL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LORENZ 1.0MM, 1.5MM, 2.0MM SYSTEM (K953385) | Walter Lorenz Surgical, Inc. | 1995-09-28 |