Recall Z-0538-2010 ยท HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
Biomet Microfixation, Inc.
Biomet 1.1 X 50MM, 3.5MM STOP STAINLESS STEEL, 1.5MM SYSTEM TWIST DRILL WITH J NOTCH, REF 01-7141. DISTRIBUTED BY: BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA. A single use twist drill intended for drilling holes in large and small bone during orthopedic, spinal, neurosurgical, medial sternotomy, and oral and maxillofacial procedures.
| Date | Dec 16, 2009 (initiated Nov 6, 2009) |
| Status | Terminated |
| Reason | 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). |
| Root cause | Process change control |
| Action | 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. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062842 | TWIST DRILL Walter Lorenz Surgical, Inc., Dec 4, 2006 |