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Recall Observatory FDA recall evidence

Device product

Vanguard Complete Knee System, Vanguard CR Lipped Tibial Bearing 10x71/75, Item Number: 183540 Product Usage: For use in total knee arthroplasty

Z-0674-2018

September 29, 2017

Class II

Product summary

Firm
Zimmer Biomet, Inc.
Event
Event 79161
Status
Terminated
Classification
Class II
Quantity
24
Official record key
device-enforcement:Z-0674-2018

Official wording

Reason: Knee implant components (tibial bearings) are labeled with the incorrect size.

Code information: Lot Number: 473290, Exp. Date 5/19/2022

Distribution pattern: Worldwide Distribution - US Nationwide in the states of CA, GA, KS, LA, MA, MI, MN, OH, TX, VA, WA, WI, and the countries of Netherlands

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Knee implant components (tibial bearings) are labeled with the incorrect size.