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Recall Observatory FDA recall evidence

Device product

XP- CR Tibial Tray- Interlok 59mm Item # 195268

Z-2503-2019

August 15, 2019

Class II

Product summary

Firm
Zimmer Biomet, Inc.
Event
Event 83594
Status
Terminated
Classification
Class II
Quantity
45 units
Official record key
device-enforcement:Z-2503-2019

Official wording

Reason: The locking bar not fully engaging

Code information: Lot Number 004960 262370 130580 004970 130630 130550 130610 130560 130570 004950 130590 279210

Distribution pattern: 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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The locking bar not fully engaging