Recall Z-2229-2010 ยท MDM Instrument, Manual, Surgical, General Use
Biomet, Inc.
SpeedPass Disposable Suture Lariat with Nitinol Wire 25 Degree Left, QTY. 1, Biomet Sports Medicine, Warsaw, IN 46581. Sterile. Part number 904010. Used to pass suture through tissue.
| Date | Aug 16, 2010 (initiated Jun 18, 2010) |
| Status | Terminated |
| Reason | The nitinol wire may be fractured or may have the potential to fracture making the suture lariat unusable and possibly delaying surgery. |
| Root cause | Component design/selection |
| Action | The firm notified all 29 consignees by An Urgent Medical Device Recall Notice letter on 6/18/2010. The letter identified the affected product and explained the reason for recall. Customers are asked to locate and remove the affected products, follow the instructions on the enclosed "FAX Back Response Form," and fax a copy of the form back prior to return of the affected product. Additionally, if product has been further distributed, then hospital personnel must be notified and given the "Dear Biomet Customer" letter. Questions should be directed to Mary Johnson at 800-348-9500 or 574-372-3 |
| Quantity | 301 units total |
| Distribution | Worldwide Distribution -- USA, including the states of FL, IL, NY, CO, MD, CA, GA, AL, PA, OH, SD, KY, TX, ID, WA, NC, AK, & MN, and Columbia and The Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.