Recall Z-2529-2019 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Zimmer Biomet, Inc.
Vanguard XP Tibial Tray 65 mm Item # 195246
| Date | Aug 15, 2019 |
| Status | Terminated |
| Reason | The locking bar not fully engaging |
| Root cause | Manufacturing material removal |
| Action | Risk Manager Responsibilities: 1.Review this notification and ensure that affected personnel are aware of the contents. 2.If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3.Complete Attachment 1 Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. This form will be returned even if you do not have affected products at your facility. 4.Retain a copy of the acknowledgement form with |
| Quantity | 43 units |
| Distribution | State NY IN OH MI GA SC FL MO WI MN ND SD NE NJ PA MD IL IA CA VA NC DC WV AR AL MS AL MI WA OR ID LA FL KS TN MA KY OK TX TX CT AZ NV NM MT WY CO UT DC WY Country: KOREA CHINA CANADA AUSTRALIA JAPAN EMEA SWEDEN ITALY |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122160 | VANGUARD XP KNEE SYSTEM Biomet Manufacturing Corp, Mar 20, 2013 |