Recall Z-1480-2009 ยท JDZ Mixer, Cement, For Clinical Use
Biomet, Inc.
Biomet Optivac Total Hip Kit, Maximum Capacity Cartridge, 1 kit, sterile, latex free, Biomet Orthopedics, Inc., Warsaw, IN; Product Number: 418000. Vacuum mixing and vacuum collection system and application system for bone cement.
| Date | Jun 30, 2009 (initiated Apr 9, 2009) |
| Status | Terminated |
| Reason | The package may contain two short mixing rods instead of one long and one short rod. |
| Root cause | Packaging process control |
| Action | Biomet Orthopedics issued an "Urgent Medical Device Recall Notice" dated April 9, 2009 instructing distributors to visit each hospital consignee, deliver a copy of the recall notification and replacement product and to pick up, and return the affected product. Further questions may be addressed to the Biomet Orthopedics at 1-800-348-9500. |
| Quantity | 250 |
| Distribution | Nationwide Distribution - Including AL, AR, FL, IL, LA, MN, NE, NC, NV, OH, OK, SC, SD, WA and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.