Biomet bone mulch screw, 10.5mm x 20 mm, TI-6AL-4V alloy, sterile, Biomet Sports Medicine, Warsaw, IN; REF 907320.
- Company
- Biomet, Inc.
- Recall Initiated
- December 22, 2009
- Posted
- February 2, 2010
- Terminated
- October 22, 2010
- Recall Number
- Z-0779-2010
- Quantity
- 169
- Firm Location
- Warsaw, IN
Reason for Recall
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.
Distribution
Arkansas, California, Delaware, Florida, Kansas, Kentucky, Michigan, Missouri, New York, Pennsylvania, South Dakota, Texas, Washington, Wisconsin, Chile, Germany, Italy, Japan and Norway.
Lot / Code Info
Lots 918790, 918800 and 110700.
Root Cause
Employee error
Action Taken
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.
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