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U.S. Department of Health and Human Services

Class 2 Device Recall AccuLIF Tubing Set

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  Class 2 Device Recall AccuLIF Tubing Set see related information
Date Initiated by Firm December 16, 2015
Create Date February 23, 2016
Recall Status1 Terminated 3 on August 01, 2016
Recall Number Z-0852-2016
Recall Event ID 73179
510(K)Number K143616  
Product Classification Intervertebral fusion device with bone graft, lumbar - Product Code MAX
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.
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.
Recalling Firm/
Manufacturer		 Stryker Spine
2 Pearl Ct
Allendale NJ 07401-1611
For Additional Information Contact Nabil Riaz
201-760-8000
Manufacturer Reason
for Recall		 There were two potential interference conditions identified with the way the tubing set attaches to the inserter.
FDA Determined
Cause 2		 Device Design
Action Stryker Spine sent an Urgent Product Removal letter dated December 17, 2015 to affected customers via Fed Ex priority overnight. The letter identified the affected product, problem and actions to be taken. Customers are asked to follow instructions included in the letter. The customer response form should be completed and sent back to email via Spine-RegulatoryActions@Stryker.com or Fax 855-632-9049. For questions call (201)749-8389.
Quantity in Commerce 413 units
Distribution US Nationwide Distribution
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MAX and Original Applicant = STRYKER CORPORATION
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