Recall Z-2065-2015 ยท HWT Template
Biomet, Inc.
Oxford Femoral Drill Guide Lateral IM Adapter Product Usage: Drill guide. The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. Partial replacement of the articulating surfaces of the knee when only one side of the knee joint is affected due to the compartmental p
| Date | Jul 14, 2015 (initiated Jun 3, 2015) |
| Status | Terminated |
| Reason | Oxford Femoral Drill Guide Lateral IM Adapter may have an undersized diameter that can cause an interference with PN: 32-422822, Oxford Microplasty IM Link. |
| Root cause | Component design/selection |
| Action | On 6/3/2015 an "URGENT MEDICAL DEVICE RECALL NOTICE" letter was sent to the affected distributors with instructions for locating and returning the affected product. The recall letter included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Questions related to this notice should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m. |
| Quantity | 18 |
| Distribution | Worldwide Distribution - US Nationwide in the states of NC, IN, PA, OH and the country of the Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.