FDA Enforcement
Class II
Terminated
Vanguard XP Tibial Tray 65 mm Item # 195246
Recall: Z-2529-2019
·
Reported September 18, 2019
Enforcement
- Recall Number
- Z-2529-2019
- Event ID
- 83594
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Zimmer Biomet, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 18, 2019
- Initiation Date
- August 15, 2019
- Classification Date
- September 12, 2019
- Termination Date
- April 16, 2021
- Address
- 56 E Bell Dr, Warsaw, IN, 46582-6989, United States
Description
Vanguard XP Tibial Tray 65 mm Item # 195246
Reason
The locking bar not fully engaging
Code Info
Lot Number 833150 332620 514900 752000 372950 752010 919200 837730 764310 764320 884350 883500 968960 968970 968980 754450 883450 584190 861150 660380
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
Quantity
43 units