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Recall Observatory FDA recall evidence

Device product

Vanguard XP Tibial Tray 69 mm Item # 195248

Z-2531-2019

August 15, 2019

Class II

Product summary

Firm
Zimmer Biomet, Inc.
Event
Event 83594
Status
Terminated
Classification
Class II
Quantity
123 units
Official record key
device-enforcement:Z-2531-2019

Official wording

Reason: The locking bar not fully engaging

Code information: Lot Number 117720 332660 373010 373000 514970 515000 372990 039210 112980 113000 112990 202920 303370 303380 590480 660400 660410 584210 590490 833180 752040 752050 752560 752060 919220 928860 754470 764360 837750 764350 846490 861180 881480 881490 928870 846500 881460 984370 984380 984360 837760 570940

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