Recall Z-0288-2009 ยท JDQ Cerclage, Fixation
Biomet, Inc.
Biomet 2.0 MM Stainless Steel (SS) Crimp Sleeve, sterile, use w/2.0 MM S.S. cable # 350800, Biomet Orthopedics, Inc., Warsaw, IN; REF. 350805. Intended for general orthopedic repairs including long bone fractures, bone grafting, reinforcement of bone and reattachment of the greater trochanter.
| Date | Nov 9, 2008 (initiated Sep 24, 2008) |
| Status | Terminated |
| Reason | The outer package is properly labeled, but the inner package may be labeled as a femoral component. |
| Root cause | Labeling mix-ups |
| Action | The firm's sales force was notified of the problem via an Urgent Medical Device Removal Notice letter dated 9/24/08, and provided instructions to retrieve the product from customer accounts and to provide them with a copy of the removal letter. Distributors were to immediately locate and remove the identified implants from circulation, carefully follow the instructions, and fax a copy of the Response Form prior to the return of the product. If the product was further distributed, hospital personnel MUST be notified via the enclosed "Dear Biomet Customer" notice. The letter MUST be given to |
| Quantity | 48 |
| Distribution | Worldwide Distribution --- USA including states of Arkansas, Florida, Kansas, New Jersey, and Ohio, and countries of Argentina, Canada, Chile Italy, Mexico and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K982545 | BMP CABLE SYSTEM Biomet, Inc., Oct 19, 1998 |