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Recall Observatory FDA recall evidence

Device product

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

Z-2876-2018

June 22, 2018

Class II

Product summary

Firm
Zimmer Biomet, Inc.
Event
Event 80548
Status
Terminated
Classification
Class II
Quantity
385
Official record key
device-enforcement:Z-2876-2018

Official wording

Reason: 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.

Code information: 63465803, 63762260, 63767434, 63799794

Distribution pattern: Worldwide Distribution - Nationwide distribution and the countries of Japan and Netherlands.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.