FDA Enforcement
Class II
Terminated
XP-CR Tibial Tray - Interlok 91 mm Item # 195279
Recall: Z-2514-2019
·
Reported September 18, 2019
Enforcement
- Recall Number
- Z-2514-2019
- 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
XP-CR Tibial Tray - Interlok 91 mm Item # 195279
Reason
The locking bar not fully engaging
Code Info
Lot Number 262480 960510 274400 274430 336060 336060R 274390 274410 279280 394540 394590 394570 821400 903420 960530 422490 512590
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
82 units