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Recall Observatory FDA recall evidence

Device product

Vanguard XP Tibial Tray 83 mm Item # 195253

Z-2536-2019

August 15, 2019

Class II

Product summary

Firm
Zimmer Biomet, Inc.
Event
Event 83594
Status
Terminated
Classification
Class II
Quantity
49 units
Official record key
device-enforcement:Z-2536-2019

Official wording

Reason: The locking bar not fully engaging

Code information: Lot Number 332760 752520 515140 754520 063070 072460 072440 072510 663350 663360 833240 919270 764460 846570 764450 837820 861240 915690 915700

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