FDA Enforcement
Class II
Terminated
XP-XP Tibial Tray - Interlok 91mm Item # 195761
Recall: Z-2516-2019
·
Reported September 18, 2019
Enforcement
- Recall Number
- Z-2516-2019
- 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-XP Tibial Tray - Interlok 91mm Item # 195761
Reason
The locking bar not fully engaging
Code Info
Lot Number 183700 790980 202030 202020 202010 986220 986240 986240R 396520 986230 394870 394840 833310 394860 903470 508690 701050 701050R
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
86 units