BIOMET MICROFIXATION, "1.5MM" SYSTEM BONE SCREW LP, SELF DRILL, X-DRIVE, SGL.LEAD AUGER POINT, 1.5 X 3.5MM, TITANIUM, NO
FDA device recall Z-1151-2010 · posted 2010-03-17 · Terminated
Recall details
- Recalling firm
- Biomet Microfixation, Inc.
- Reason for recall
- Biomet Microfixation is recalling Model 01-7293 an Model 99-7293-01, 1.5X3.5mm Self Drilling, Low Profile, Cross Drive screw, 5/PK was found to contain a 91-6104 (1.5X4mm High Torque, Self Drilling, Cross Drive screw.
- Action taken
- Biomet Microfixation Issued an "Urgent Medical Device Recall Notice". Consignees were notified of the recall instructed to indentify and return all affected product to the firm. An Inventory Reconciliation sheet should be completed and faxed to 1-904-741-9425. For further information, contact Biomet Microfixation, Global Complaint Coordinator at 1-800-874-7711 or 904-741-4400, extension 468, Monday through Friday, 8am-4pm ET.
- Root cause
- Process control
- Status
- Terminated
- Product code
- JEY
- Quantity affected
- 831 screws
- Distribution
- Worldwide Distribution -- United States (WI), Spain, Italy, Japan, Brazil and Korea.
- Date initiated
- 2009-10-06
- Date posted
- 2010-03-17
- Date terminated
- 2010-04-07
- 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 |