FDA-Device2018-08-29Class II
Persona Partial Knee System Spacer Block Alignment Tower, Item No. 42-5399-006-35 Product Usage: Intended to aid in preparatory surgical procedures
Zimmer Biomet, Inc.
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.
Sold states
Worldwide Distribution - Nationwide distribution and the countries of Japan and Netherlands.
Affected count
385
Manufactured in
56 E Bell Dr, Warsaw, IN, United States
Products
Persona Partial Knee System Spacer Block Alignment Tower, Item No. 42-5399-006-35 Product Usage: Intended to aid in preparatory surgical procedures
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2876-2018Don't want to check this manually?
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