Recall Z-2242-2014 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Biomet, Inc.
Vanguard 360 Femoral Boss Reamer, Label: REF 32-488474 VANGUARD 360 1NSTRUMENT FEMORAL BOSS REAMER NON-STERILE, BIOMET ORTHOPEDICS 56 EAST BELL DRIVE P.O. BOX 587 WARSAW, IN 46581 USA
| Date | Aug 15, 2014 (initiated Jul 1, 2014) |
| Status | Terminated |
| Reason | The Vanguard 360 Femoral Boss Reamers were manufactured oversized to the print. The instrument may not fit into the mating component. |
| Root cause | Process change control |
| Action | Urgent Medical Device Recall Notices dated July 15, 2014 were mailed with verification of delivery via FedEx. Response forms were provided to all consignees in order for Biomet to track returns. The letters informed the consignees to return the devices to Biomet and conduct a sub-recall sending the recall letter to all customers. |
| Quantity | 461 |
| Distribution | California, IA, FL, MD, UT, SC, AL, IL, CO, MA, KS, GA, WA, NV, AR, NH, OK,Pennsylvania, New York, Texas, Virginia, New Jersey, North Carolina, Kentucky, Michigan, Ohio, Wisconsin, Louisiana, Arizona, Indiana, South Dakota, Missouri & Montana. In addition to Korea, B.V., Japan, Puerto Rico, UK, Chi |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093293 | VANGUARD 360 REVISION KNEE SYSTEM Biomet, Inc., Oct 22, 2010 |