Recall Z-0779-2010 ยท HWC Screw, Fixation, Bone
Biomet, Inc.
Biomet bone mulch screw, 10.5mm x 20 mm, TI-6AL-4V alloy, sterile, Biomet Sports Medicine, Warsaw, IN; REF 907320.
| Date | Feb 2, 2010 (initiated Dec 22, 2009) |
| Status | Terminated |
| Reason | The screw may not have the hex dimension inside of the head of the screw, which will prevent the device from being implantable. This may cause a delay in the procedure while another screw is obtained. |
| Root cause | Employee error |
| Action | Hospitals, distributors, and other customers were notified by letter dated 12/22/09 and instructed to locate and return these lots of product. Questions related to this notice should be directed to the firm at 800-348-9500 or 574-372-3983, Monday through Friday, 8AM to 5PM. |
| Quantity | 169 |
| Distribution | Arkansas, California, Delaware, Florida, Kansas, Kentucky, Michigan, Missouri, New York, Pennsylvania, South Dakota, Texas, Washington, Wisconsin, Chile, Germany, Italy, Japan and Norway. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K941941 | BONE MULCH SCREW Biomet, Inc., Feb 2, 1995 |