Biomet bone mulch screw, 10.5mm x 20 mm, TI-6AL-4V alloy, sterile, Biomet Sports Medicine, Warsaw, IN; REF 907320.
FDA device recall Z-0779-2010 · posted 2010-02-02 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- 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.
- 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.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- HWC
- Quantity affected
- 169
- Distribution
- Arkansas, California, Delaware, Florida, Kansas, Kentucky, Michigan, Missouri, New York, Pennsylvania, South Dakota, Texas, Washington, Wisconsin, Chile, Germany, Italy, Japan and Norway.
- Date initiated
- 2009-12-22
- Date posted
- 2010-02-02
- Date terminated
- 2010-10-22
- Location
- Warsaw, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BONE MULCH SCREW (K941941) | Biomet, Inc. | 1995-02-02 |