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Recall Observatory FDA recall evidence

Device product

Vanguard XP Tibial Tray 73 mm Item # 195250

Z-2533-2019

August 15, 2019

Class II

Product summary

Firm
Zimmer Biomet, Inc.
Event
Event 83594
Status
Terminated
Classification
Class II
Quantity
84 units
Official record key
device-enforcement:Z-2533-2019

Official wording

Reason: The locking bar not fully engaging

Code information: Lot Number 590540 590530 590520 663190 590550 663200 907710 117740 332690 833210 752580 373050 373060 515050 752120 515070 752100 752110 754490 764390 861210 837790 936210 764400 846520 928890 907690 936220 936230 954050 928880 936200 954030 907700 063000 062990 570980 584230

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