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Recall Observatory FDA recall evidence

Device product

Vanguard Knee System -PS Open Box Femoral Right, 65 mm Item Number:183108

Z-0496-2019

October 22, 2018

Class II

Product summary

Firm
Zimmer Biomet, Inc.
Event
Event 81472
Status
Terminated
Classification
Class II
Quantity
8 units
Official record key
device-enforcement:Z-0496-2019

Official wording

Reason: Label on the outer carton or the patient labels does not match label on the inner sterile packaging

Code information: Lot Number: J6265594 UDI: (01)00880304270893(17)280411(10)J6255863

Distribution pattern: AR, MO, MN, NJ, NY, OH, MN , NJ, VA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Label on the outer carton or the patient labels does not match label on the inner sterile packaging