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Recall Observatory FDA recall evidence

Device product

Vanguard XP Tibial Tray 65 mm Item # 195246

Z-2529-2019

August 15, 2019

Class II

Product summary

Firm
Zimmer Biomet, Inc.
Event
Event 83594
Status
Terminated
Classification
Class II
Quantity
43 units
Official record key
device-enforcement:Z-2529-2019

Official wording

Reason: The locking bar not fully engaging

Code information: Lot Number 833150 332620 514900 752000 372950 752010 919200 837730 764310 764320 884350 883500 968960 968970 968980 754450 883450 584190 861150 660380

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