FDA Enforcement
Class II
Terminated
Vanguard XP Tibial Tray 63 mm Item # 195245
Recall: Z-2528-2019
·
Reported September 18, 2019
Enforcement
- Recall Number
- Z-2528-2019
- 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 63 mm Item # 195245
Reason
The locking bar not fully engaging
Code Info
Lot Number 833140 332580 514890 764300 754440 837720 999580 999590 999570 764290 999610 090060 090020
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
8 units