Recall Z-1952-2010 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
Biomet, Inc.
Artificial ligament fixation device # 7PE ZIPLOOP Extended Toggle, Sterile, REF 904755, Biomet Sports Medicine Warsaw, IN. Intended for soft tissue to bone fixation.
| Date | Jul 1, 2010 (initiated Mar 31, 2010) |
| Status | Terminated |
| Reason | The firm has received complaints that the saddle is too long. The saddle is supposed to be between 7/8 and 1 1/8 inches long. The saddle in the complaints was up to 1.9 inches long. |
| Root cause | Process control |
| Action | Biomet Sports Medicine issued an "Urgent Medical Device Recall Notice" dated March 31, 2010 to user facilities and distributors. A second notification containing updated information was issued June 2, 2010. Consignees were instructed to discontinue use of the product and return it to the firm along with a completed Response Form. For further information, contact Biomet at 1-574-371-3755 or 1-574-371-3756, Monday through Friday, 8AM to 5PM. |
| Quantity | 2466 both products |
| Distribution | Worldwide Distribution -- United States, Canada, Australia, The Netherlands, Belgium, Italy, France, New Zealand, Austria, United Kingdom, Chile, Greece, Poland, Denmark, Turkey, Portugal, South Africa and Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083070 | TOGGLELOC SYSTEM Biomet Sports Medicine, Dec 16, 2008 |