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Recall Observatory FDA recall evidence

Device product

XP-CR Tibial Tray - Interlok 87 mm Item # 195278

Z-2513-2019

August 15, 2019

Class II

Product summary

Firm
Zimmer Biomet, Inc.
Event
Event 83594
Status
Terminated
Classification
Class II
Quantity
78 units
Official record key
device-enforcement:Z-2513-2019

Official wording

Reason: The locking bar not fully engaging

Code information: Lot Number 966230 262470 587200 274370 274360 274380 274420 715690 274420R 715690R 393650 279080 394490 821380 903430 943440 422480 512580

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