Stryker Spine recalls AccuLIF PL Tubing Set and AccuLIF TL Tubing Set AccuLIF is an interbody device system that uses hydraulic pressure to e…

Recall date

December 16, 2015

Source

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

Recall number

Z-0852-2016

FDA classification

Class II

Brand / firm

Stryker Spine

Sold / distributed

US Nationwide Distribution

Why it was recalled

There were two potential interference conditions identified with the way the tubing set attaches to the inserter.

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

What was recalled

AccuLIF PL Tubing Set and AccuLIF TL Tubing Set AccuLIF is an interbody device system that uses hydraulic pressure to expand the implant in-situ. The purpose of the AccuLIF PL Tubing Set (cat#900301) and AccuLIF TL Tubing Set (cat#905103) is to deliver pressurized saline from a syringe to the AccuLIF implant for in-situ expansion. The Tubing Set attaches to the AccuLIF Insertion handle at two district locations: the "junction block" and the "manifold." The PL and TL Tubing Sets are Class 2 instruments not intended to sustain or support life.