Class 2 Device Recall G3 Opticage Expandable Interbody Fusion Device

• Date Initiated by Firm: November 22, 2016
• Date Posted: January 03, 2017
• Recall Status: Terminated on February 07, 2017
• Recall Number: Z-0941-2017
• Recall Event ID: 75882
• 510(K)Number: K152156 K160464
• Product Classification: Intervertebral fusion device with bone graft, lumbar - Product Code MAX
• Product: G3 Opticage Expandable Interbody Fusion Device, Model No. 9180-00, 9180-01, 9180-06, 9180-07, 9180-17, 9101-00, 9101-06; The Opticage Expandable Interbody Fusion Device is a posterior lumbar intervertebral body fusion device and is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Opticage Interbody Fusion Device can be implanted via posterior, transforaminal or lateral approach. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Candidates for surgery should be skeletally mature and have had six months of conservative treatment. These patients may have had primary or secondary surgery, but no previous fusion at the involved levels. The device is not intended to be used as a stand-alone device. It must be used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine (i.e. facet screw fixation systems, facet compression devices and posterior pedicle screw and rod systems).
• Code Information: Lot no. 011416-D 021216-A 021216-B 032015-B 032015-C 033116-B 040915-B 040915-E 041416-A 060116-A 060116-B 060116-C 061616-B 061915-A 061915-B 070714-D 071116-A 071116-B 071116-C 071516-A 071516-B 071916-A 081016-A 081016-B 081016-C 083116-B 083116-B 091516-A 112515-A 033116-C 030716-A 081016-E 090216-C 090216-C 090216-D 030716-B 011416-E 021216-C 081016-F 081016-G 090216-A 090216-A 090216-B 081016-H 083116-C 083116-C 083116-D
• Recalling Firm/ Manufacturer: Interventional Spine Inc; 13700 Alton Pkwy Ste 160; Irvine CA 92618-1618
• Manufacturer Reason for Recall: During implantation, the proximal end of the device could separate if the angle between the device and insertion instrument is too steep. This separation will prevent the device from expanding.
• FDA Determined Cause: Device Design
• Action: Interventional Spince, Inc. sent an An Urgent Medical Device Recall letter dated November 22, 2016, to all affected customers to inform them that during implantation, the proximal end of the device could separate if the angle between the device and insertion instrument is too steep. This separation will prevent the device from expanding. The letter informs the customers of the risk to health and actions to be taken by the customer/user. Customers were instructed to discontinue use and return device per the enclosed instructions. Complete the enclosed acknowledgment letter and fax, email or mail it to Interventional Spine. Customers with questions were instructed to call Monday through Friday 8am to 5pm (Pacific Time), 949-472-0006 or email cs@i-spineinc.com.
• Quantity in Commerce: 239 units
• Distribution: Nationwide Distribution to NY, NC, SC, PA, TX, OH, GA, NJ, DE, AZ, DC, CA, and VA.
• 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 = INTERVENTIONAL SPINE, INC.