Recall Z-2370-2008 ยท GFA Blade, Saw, General & Plastic Surgery, Surgical
Biomet, Inc.
Exact Calcar Planer Rasp Style Blade, 38mm, Biomet Orthopedics, Inc, Warsaw, IN; REF 31-473795. Surgical blades used to remove excess bone proximal to the broach face to all instrument trial to seat properly.
| Date | Sep 29, 2008 (initiated Jul 18, 2008) |
| Status | Terminated |
| Reason | The blades will oxidize after the first cleaning. |
| Root cause | Process control |
| Action | Distributors were notified via letter dated 7/18/08 to locate and remove the products and to return them. Distributors were instructed to conduct the recall to the hospital level and to notify the hospitals of the recall by copy of an undated recall letter. Contact Biomet, Inc. at 1-800-348-9500, ext. 3983 for assistance. |
| Quantity | 141 of all products |
| Distribution | Nationwide and China. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.