Recall Z-0673-2018 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Zimmer Biomet, Inc.
Vanguard Complete Knee System, Vanguard CR Tibial Bearing 12x71/75, Item Number: 183442 Product Usage: For use in total knee arthroplasty
| Date | Sep 29, 2017 |
| Status | Terminated |
| Reason | Knee implant components (tibial bearings) are labeled with the incorrect size. |
| Root cause | Labeling mix-ups |
| Action | Zimmer Biomet sent an Urgent Medical Device Recall letter dated September 29, 2017 to their customers. The letter identified the affected product, problems and actions to be taken. Customers were instructed to remove the affected product from inventory and provide to their Zimmer sales representative or, if the consignee is a distributor, to ship the affected product back to Zimmer. Consignees were also asked to complete a recall response form and send this back to the firm. Returns are being physically destroyed. If you have further questions or concerns after reviewing this notice, please |
| Quantity | 24 |
| Distribution | Worldwide Distribution - US Nationwide in the states of CA, GA, KS, LA, MA, MI, MN, OH, TX, VA, WA, WI, and the countries of Netherlands |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023546 | MAXIM ACCEL KNEE SYSTEM Biomet, Inc., Jan 17, 2003 |