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Recall Observatory FDA recall evidence

Device product

XP-CR Tibial Tray - Interlok 79 mm Item # 195276

Z-2511-2019

August 15, 2019

Class II

Product summary

Firm
Zimmer Biomet, Inc.
Event
Event 83594
Status
Terminated
Classification
Class II
Quantity
319 units
Official record key
device-enforcement:Z-2511-2019

Official wording

Reason: The locking bar not fully engaging

Code information: Lot Number 663820 503480 262450 308140 308150 473010 513130 320340 320590 579060 571060 938200 322150 066240 283270 322200 851360 996030 996030R 090250 841560 206870 322180 258110 279270 553900 711510 161980 161990 274450 043940 041260 663840 041170 993800 883570 883600 883590 883580 888420 374120 599170 576060 279060 712600 576050 672660 821370 600820 717210 943420 221180 141500 199770 450380 220060 502880 513120

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