Recall Z-0493-2014 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Biomet, Inc.
G7 Acetabular Screw 6.5mmx35mm Part Number: 010001000
| Date | Dec 13, 2013 (initiated Nov 26, 13) |
| Status | Terminated |
| Reason | Investigation identified that the outer label, inner label, and patient label all have the incorrect diameter size of 10.5mm. The screw is actually a 6.5mm diameter and correctly corresponds to the items number on the label. |
| Root cause | Labeling Change Control |
| Action | Beginning November 25 Urgent recall electronic notices were sent by Biomet UK to all distributors with hospitals outside the USA notified by ground mail November 27,2013. The notification identified the product and reason for the recall, asking for immediate location and discontinued use of the product and return to Biomet UK, Ltd. Questions can be addressed to Biomet USA at 01 574-372-1570 M-F 8 am to 5 pm. |
| Quantity | 532 in USA all under Biomet USA control |
| Distribution | Worldwide Distribution - USA Nationwide and in the countries of Europe, Italy, UK, Australia, Japan. all product in USA is under Biomet control. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.