Recall Z-0367-2010 ยท FZX Guide, Surgical, Instrument
Biomet, Inc.
Biomet K-Wire/Trocar Point, both ends/Dia. 045, length: 9 in., certified stainless steel, sterile, Biomet Orthopedics, Inc., Warsaw, IN; REF 35-351534. Internal fixation devices intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. The devices can also be used as instrument accessories to stabilize cut blocks and can serve as guide wire
| Date | Nov 19, 2009 (initiated Aug 6, 2009) |
| Status | Terminated |
| Reason | Packages labeled as having a .045 inch diameter trocar point actually contain a diamond point with a diameter of .062 inches. |
| Root cause | Process control |
| Action | An "Urgent Medical Device Recall Notice" dated August 6, 2009 was issued to consignees. The letter described the affected product, issue and actions for consignees. Customers were instructed to complete and return the "FAX back Response Form" (fax number 1-574-372-1683) and all affected product in inventory to Biomet Orthopedics. Direct questions related to the recall notification by calling at 1-800-348- 9500 or 1-574-372-3983, Monday through Friday, 8AM to 5PM. |
| Quantity | 19 |
| Distribution | United States (Florida and Pennsylvania). |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.