FDA Enforcement
Class II
Terminated
XP-CR Tibial Tray - Interlok 87 mm Item # 195278
Recall: Z-2513-2019
·
Reported September 18, 2019
Enforcement
- Recall Number
- Z-2513-2019
- 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 87 mm Item # 195278
Reason
The locking bar not fully engaging
Code Info
Lot Number 966230 262470 587200 274370 274360 274380 274420 715690 274420R 715690R 393650 279080 394490 821380 903430 943440 422480 512580
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
78 units