Recall Z-0852-2016— Stryker Spine

Name: FDA recall Z-0852-2016
Creator: U.S. Food and Drug Administration
Published: 2015-12-16

Class II · Terminated

Class II FDA medical device recall by Stryker Spine, initiated 2015-12-16, terminated 2016-08-01. It names one FDA 510(k) clearance: K143616. 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.. Reason: There were two potential interference conditions identified with the way the tubing set attaches to the inserter..

Recalling firm: Stryker Spine
Classification: Class II
Status: Terminated
Initiated: 2015-12-16
Terminated: 2016-08-01
Firm location: Allendale, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K143616 — AccuLIF TL and PL CageStryker Corporation·cleared 2015-03-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.