device · product 1 of 1
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.
- Recall number
- Z-0852-2016
- Initiated
- December 16, 2015
- Classification
- Class II
- Status
- Terminated
- Recalling firm
- Stryker Spine
- Quantity
- 413 units
App-derived interpretation
Unknown
There were two potential interference conditions identified with the way the tubing set attaches to the inserter.
Official device-enrichment evidence · Sourced
Device Design
Inspect official wording and provenance
Reason for recall
There were two potential interference conditions identified with the way the tubing set attaches to the inserter.
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.
Distribution pattern
US Nationwide Distribution