Z-0852-2016 Class II Terminated
FDA device recall Z-0852-2016 was initiated by Stryker Spine on December 16, 2015 and is designated Class II. Reason for recall: There were two potential interference conditions identified with the way the tubing set attaches to the inserter. The recall status is terminated (terminated August 1, 2016). Affected quantity: 413 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 2, 2016
- Initiation Date
- December 16, 2015
- Termination Date
- August 1, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 413 units
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.
Distribution Pattern
US Nationwide Distribution
Code Information
Catalog number 900301, Lot #01131543, 01261508, 10151404, 10271408, 12161403, 12161404, 09021404, 01261509, 10271407, 01261507, 10071415, 05011403, 06241407, 08071402, 10091305, 03041403, 01271412, 07281401, and 11061303. Catalog number 905103, 01131542, 11241408, 12161405, 12161406, 0211501, 01211502, 11241406, 02031403, 06241408, 07161407, 09101402, 09281401, 10251303, 05301402, 11241407, and 12101305.