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Stryker Spine recalls AccuLIF PL Tubing Set and AccuLIF TL Tubing Set AccuLIF is an interbody device system that uses hydraulic pressure to
Recalled March 2, 2016 · FDA recall Z-0852-2016 · Stryker Spine
Hazard
There were two potential interference conditions identified with the way the tubing set attaches to the inserter. · FDA Class II
Units
413 units
Sold at
US Nationwide Distribution
Description
There were two potential interference conditions identified with the way the tubing set attaches to the inserter.
Product
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.
Manufacturer(s)
Stryker Spine
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →