Recall Z-0076-2012 ยท FZX Guide, Surgical, Instrument
Biomet, Inc.
MICROPLASTY TAPERLOC 7.5 MM RESECTION GUIDE, STAINLESS STEEL, BIOMET ORTHOPEDICS 56 EAST BELL DRIVE PO BOX 587 WARSAW IN 46582 USA. This device is used to mark the femoral neck resection level
| Date | Oct 20, 2011 (initiated Sep 16, 2011) |
| Status | Terminated |
| Reason | Biomet has initiated this action following an investigation which identified that the blueprint calls for engraved measurements on both sides on the Microplasty Taperloc 7.5MM Resection Guide. The above lots, as supplied to Biomet by a vendor, are engraved on only one side. To date, Biomet has received 2 reports involving 2 units where the instrument was missing the engraving on one side. |
| Root cause | Nonconforming Material/Component |
| Action | Biomet sent an "URGENT MEDICAL DEVICE RECALL NOTICE" dated September 16, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to locate and discontinue use of the affected product. Arrangements will be made for customers to return the affected product to Biomet. To confirm receipt of this notice call Biomet at 800-348-9500 ext. 3755 or 3756. Questions related to this notice should be directed to 574-371-3755 or 3756, Monday through Friday, 8 AM to 5 PM. |
| Quantity | 22 |
| Distribution | Worldwide Distribution-USA (nationwide) including the states of AL, CA, IN, MI, OK, and VA and countries of Australia and Chile. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.