Recall Z-1782-2008 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
Biomet Sports Medicine
BIOMET EZLoc 7-8mm TM Femoral Fixation, Catalog Number 904780. The Ezloc Is indicated for use for fixation of tendons & ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) reconstruction.
| Date | Sep 4, 2008 (initiated Apr 17, 2008) |
| Status | Terminated |
| Reason | This recall was initiated following an investigation which identified that: EZLoc Femoral Fixation devices, from two finished good lots were distributed with the incorrect component size inside the package. As supplied, label indicates product size as EZLoc 7-8mm 904780 L305240. Actual product enclosed may be EZLoc 9-10mm. Alternatively, as supplied, label indicates product size as EZLoc 9-1 |
| Root cause | Employee error |
| Action | An Urgent Medical Device Removal Notice was issued by BIOMET on May 2, 2008, to all customers in the United States via overnight carrier (UPS). The U.S. Removal Notice was used as a template for all global communications regarding this urgent removal notice. Included in this recall correspondence were three Recall Letters; one for direct customers, one for Physicians and one for distributors. The notice informed customers of the problem and the risks associated with the use of this product (note: The Physician letter included more detail instruction for physician with patients already impl |
| Quantity | 80 |
| Distribution | Class II Recall - Worldwide Distribution --- including USA and countries of Argentina, Chile, Italy, Netherlands, Norway & Poland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041261 | FEMORAL HOOK Arthrotek, Inc., Jun 7, 2004 |