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Recall Observatory FDA recall evidence

Device product

Vanguard Knee System Series-A Standard Patella sizes 31mm Item Number: 184764

Z-0937-2019

December 21, 2018

Class II

Product summary

Firm
Zimmer Biomet, Inc.
Event
Event 82004
Status
Terminated
Classification
Class II
Quantity
45 units
Official record key
device-enforcement:Z-0937-2019

Official wording

Reason: Vanguard Knee System Series-A Standard Patella a potential commingle that could result in the size of the implant not matching the size on the label.

Code information: Lot Number: 399960 UDI Number: (01)00880304431317(17)230302(10)399960

Distribution pattern: MN, VA Foreign: Korea, New Zealand and Japan

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Vanguard Knee System Series-A Standard Patella a potential commingle that could result in the size of the implant not matching the size on the label.