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Recall Observatory FDA recall evidence

Device product

Vanguard XP Tibial Tray 71 mm Item # 195249

Z-2532-2019

August 15, 2019

Class II

Product summary

Firm
Zimmer Biomet, Inc.
Event
Event 83594
Status
Terminated
Classification
Class II
Quantity
Unavailable
Official record key
device-enforcement:Z-2532-2019

Official wording

Reason: The locking bar not fully engaging

Code information: Lot Number 584220 590500 590510 663160 663180 663170 660420 117730 332670 833200 373020 373040 373030 515030 515020 515040 752090 752070 752080 919240 919230 846510 764370 764380 837780 754480 837770 861200 881500 881510 984430 984400 039230 052240 039240 881530 984390 039220 984420 052260 984410 090340 570960

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