Recall Z-1521-2012 ยท JXE Device, Nerve Conduction Velocity Measurement
Biomet, Inc.
Ultra-DriveTool, 6 MM Plug Puller, REF 423868. Recommended Power Setting 70 For Single Use Only, Sterile, Biomet Orthopedics, Warsaw, IN 46581 Incorrect Picture Label, Trochanter Plate (50-60 mm) Mallory/Head The Ultra-DriveTM System is used to aid in the removal of bone cement (PMMA) and noncemented implants in conjunction with revision arthroplasty. The Ultra-Drive" device converts standard
| Date | May 10, 2012 (initiated Apr 18, 2012) |
| Status | Terminated |
| Reason | Incorrect product picture label was on the product box. |
| Root cause | Process design |
| Action | Biomet Orthopedics sent an Urgent Medical Device Recall Notice dated April 18,2012, to all affected customers. The letter identified the reason for the recall including directions to immediately locate, discontinue use of the device, and return product to Biomet, 56 East Bell Drive, Warsaw, IN 46580. Consignees were asked to confirm receipt of the notice by calling 1-800-348-9500 extension 3983 or 3009. A FAX Back Response Form was to be filled out and sent within 3 days of receipt to 574-372-1683. Questions related to the notice should be directed to 474-372-3983 or 574-371-3009, Monday |
| Quantity | 30 units |
| Distribution | Worldwide Distribution - USA (nationwide) and Europe, Austrailia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031280 | ULTRA-DRIVE 3 Biomet, Inc., Sep 22, 2003 |