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FDAJune 22, 2018device

Persona Partial Knee System Spacer Block Alignment Tower, Item No. 42-5399-006-35 Product Usage: Intended to aid in preparatory surgical procedures

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

The hazard

The PPK System Spacer Block Alignment Tower mating feature that mates with the spacer block was undersized, which could potentially lead to mating issues between the devices. This could cause a delay in surgery of less than 30 minutes. There is an option in the surgical technique for performing limb alignment without the alignment tower.

What to do

FDA enforcement status: Terminated

Brands named

zimmer biometzimmer

UPCs

42539900635

Recall history

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

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