Biomet 1.1 X 50MM, 3.5MM STOP STAINLESS STEEL, 1.5MM SYSTEM TWIST DRILL WITH J NOTCH, REF 01-7141. DISTRIBUTED BY: BIOME
FDA device recall Z-0538-2010 · posted 2009-12-16 · Terminated
Recall details
- Recalling firm
- Biomet Microfixation, Inc.
- Reason for recall
- The Twist Drill 1.1x50mm, 3.5mm stop, with J notch Lots #'s 537407, 536306, and 535933 which were packaged and shipped without the instructions for use (IFU).
- Action taken
- Consignees were notified of the recall by a combination of telephone calls, letters, and emails during the week of November 16, 2009. Customers were instructed to complete the Inventory Reconciliation Sheet and fax (1-904-741-9425) to the firm. Customers who further distributed the affected product was instructed to notify recipients of the recall. Direct questions about the recall to Biomet Microfixation, Inc. by calling 1-800-874-7711 or 1-904-741-4400, extension 468, Monday through Friday, 8 a.m. to 4 p.m. Eastern Standard Time.
- Root cause
- Process change control
- Status
- Terminated
- Product code
- HBE
- Quantity affected
- 283 pieces
- Distribution
- Worldwide Distribution -- United States (including Puerto Rico), Australia, Brazil, Canada, Chile, Europe, France, Germany, Greece, Japan, Lebanon, Spain, and the United Arab Emirates.
- Date initiated
- 2009-11-06
- Date posted
- 2009-12-16
- Date terminated
- 2010-03-02
- Location
- Jacksonville, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TWIST DRILL (K062842) | Walter Lorenz Surgical, Inc. | 2006-12-04 |