FDA recall Z-2876-2018

Product

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

Reason for recall

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.

Distribution

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

Key facts

Status

Terminated

Initiation date

2018-06-22

Report date

2018-08-29

Termination date

2019-10-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2876-2018