Z-1350-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 18, 2018
- Initiation Date
- January 18, 2018
- Termination Date
- July 13, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6
Product Description
Spinal Jaxx Interbody Fusion Device, Model: 100001-511, Size: 9 H x 10 W x 25 L Product Usage: The Spinal Jaxx interbody fusion device is indicated for spinal fusion for patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The indicated patient population is skeletally mature patients who have had six (6) months of non-operative treatment. The Spinal Jaxx interbody fusion device must be used with autogenous bone graft material and with supplemental fixation.
Reason for Recall
The implant size is incorrectly etched on the implant. The size listed on the box is correct.
Distribution Pattern
The devices were distributed in California.
Code Information
Lot 1599, Expiration date: 10/03/2018