Recall Z-1011-2018 ยท MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Zimmer Biomet, Inc.
Vanguard CR Porous Femoral 62.5mm (Left Femur) For use in total knee arthroplasty
| Date | Oct 3, 2017 |
| Status | Terminated |
| Reason | The affected products are labeled as a 62.5mm LEFT Femur; however, the contents are a Vanguard 70mm RIGHT Femur. |
| Root cause | Error in labeling |
| Action | The firm, Zimmer Biomet, sent an "URGENT MEDICAL DEVICE RECALL REMOVAL" letter dated October 3, 2017 to distributors and customers. The letter described the product, problem and actions to be taken. The customers were instructed to: 1. Review notification and ensure affected team member are aware of the contents 2. Immediately locate and quarantine affected product in your inventory. 3. Complete the Certification of Acknowledgement portion of Attachment 1 Inventory Return Certification Form via digital copy to: corporatequallity.postmarket@zimmerbiomet.com within three (3) days. 4. Immediatel |
| Quantity | 8 |
| Distribution | US Distribution to states of: FL, WI, MD, MO, and MI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113550 | VANGUARD COMPLETE KNEE SYSTEM Biomet Manufacturing Corp, Feb 29, 2012 |