FDA Enforcement
Class II
Terminated
Vanguard XP Tibial Tray 83 mm Item # 195253
Recall: Z-2536-2019
·
Reported September 18, 2019
Enforcement
- Recall Number
- Z-2536-2019
- 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 83 mm Item # 195253
Reason
The locking bar not fully engaging
Code Info
Lot Number 332760 752520 515140 754520 063070 072460 072440 072510 663350 663360 833240 919270 764460 846570 764450 837820 861240 915690 915700
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
49 units