FDA Enforcement
Class II
Terminated
Vanguard XP Tibial Tray 69 mm Item # 195248
Recall: Z-2531-2019
·
Reported September 18, 2019
Enforcement
- Recall Number
- Z-2531-2019
- 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 69 mm Item # 195248
Reason
The locking bar not fully engaging
Code Info
Lot Number 117720 332660 373010 373000 514970 515000 372990 039210 112980 113000 112990 202920 303370 303380 590480 660400 660410 584210 590490 833180 752040 752050 752560 752060 919220 928860 754470 764360 837750 764350 846490 861180 881480 881490 928870 846500 881460 984370 984380 984360 837760 570940
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
123 units