FDA Enforcement
Class II
Terminated
Vanguard XP Tibial Tray 79 mm Item # 195252
Recall: Z-2535-2019
·
Reported September 18, 2019
Enforcement
- Recall Number
- Z-2535-2019
- 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 79 mm Item # 195252
Reason
The locking bar not fully engaging
Code Info
Lot Number 332750 833230 515120 752550 515130 373090 919280 754510 764430 764440 861230 837810 846560 907730 928810 907720 907740 969000 969010 590620 590600 663320 663330 663340 590610 571010 663310
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
99 units