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FDAJanuary 4, 2017device

Vanguard Total Knee System Vanguard Open Box Femoral Components Item Number: 183100 Description: VNGD PS OPEN INTL FEM RT 55 Item Number: 183102 Description: VNGD PS OPEN INTL FEM-RT 57.5 Item Number: 183104 Description: VNGD PS OPEN INTL FEM RT 60 Item Number: 183106 Description: VAN PS OPEN INT...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

packaging of some femoral components was incorrectly labeled as either smaller or larger and/or as the incorrect side (right/left). Risk delay in surgery.

What to do

FDA enforcement status: Terminated

Brands named

zimmer biometzimmer

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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