Recall Z-0538-2010
Biomet Microfixation, Inc. · initiated November 6, 2009
Product
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.
Codes / lots: Lots: 535933, 536306 and 537407.
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).
FDA-determined cause: Process change control
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.
Details
- Recall number
- Z-0538-2010
- Initiated
- November 6, 2009
- Posted by FDA
- December 16, 2009
- Terminated
- March 2, 2010
- Product code
- HBE – Drills, Burrs, Trephines & Accessories (Simple, Powered)
- 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.
- Recalling firm
- Biomet Microfixation, Inc., Jacksonville, FL