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Recall Observatory FDA recall evidence

Device product

Vanguard XP Tibial Tray 67 mm Item # 195247

Z-2530-2019

August 15, 2019

Class II

Product summary

Firm
Zimmer Biomet, Inc.
Event
Event 83594
Status
Terminated
Classification
Class II
Quantity
74 units
Official record key
device-enforcement:Z-2530-2019

Official wording

Reason: The locking bar not fully engaging

Code information: Lot Number 332640 833160 514940 372960 372970 514920 752020 752030 919210 764330 754460 884550 837740 764340 861170 884360 887950 935780 935800 953910 968990 953950 928850 936190 953930 953940 861160 663120 660390 663080 663110 584200

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