Recall Z-1953-2010 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
Biomet, Inc.
Toggleloc Artificial ligament fixation device ZIPLOOP Technology Implant Kit, Sterile, REF 909848, 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 |