Zimmer Biomet, Inc. recalls Persona Partial Knee System Spacer Block Alignment Tower, Item No. 42-5399-006-35 Product Usage: Intended to aid in pre…

Recall date

June 22, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2876-2018

FDA classification

Class II

Brand / firm

Zimmer Biomet, Inc.

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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