Z-0941-2017 Class II Terminated
FDA device recall Z-0941-2017 was initiated by Interventional Spine Inc on November 22, 2016 and is designated Class II. 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. The recall status is terminated (terminated February 7, 2017). Affected quantity: 239 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 11, 2017
- Initiation Date
- November 22, 2016
- Termination Date
- February 7, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 239 units
Product Description
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).
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.
Distribution Pattern
Nationwide Distribution to NY, NC, SC, PA, TX, OH, GA, NJ, DE, AZ, DC, CA, and VA.
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