FDA Enforcement
Class II
Terminated
Vanguard XP Tibial Tray 73 mm Item # 195250
Recall: Z-2533-2019
·
Reported September 18, 2019
Enforcement
- Recall Number
- Z-2533-2019
- 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 73 mm Item # 195250
Reason
The locking bar not fully engaging
Code Info
Lot Number 590540 590530 590520 663190 590550 663200 907710 117740 332690 833210 752580 373050 373060 515050 752120 515070 752100 752110 754490 764390 861210 837790 936210 764400 846520 928890 907690 936220 936230 954050 928880 936200 954030 907700 063000 062990 570980 584230
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
84 units