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Recall Observatory FDA recall evidence

Device product

Vanguard XP Tibial Tray 79 mm Item # 195252

Z-2535-2019

August 15, 2019

Class II

Product summary

Firm
Zimmer Biomet, Inc.
Event
Event 83594
Status
Terminated
Classification
Class II
Quantity
99 units
Official record key
device-enforcement:Z-2535-2019

Official wording

Reason: The locking bar not fully engaging

Code information: Lot Number 332750 833230 515120 752550 515130 373090 919280 754510 764430 764440 861230 837810 846560 907730 928810 907720 907740 969000 969010 590620 590600 663320 663330 663340 590610 571010 663310

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