Recall Z-1253-2016 ยท OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Biomet Spine, LLC
10mm X 12o Solitaire Ti Medium Spacer Solitaire Anterior Spinal System, Model Number 1400-1230. Product Usage: The SOLITAIRETM SPINAL SYSTEM is designed for use with autograft and is indicated for stand-alone intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at t
| Date | Feb 12, 2016 |
| Status | Terminated |
| Reason | Zimmer Biomet Spine initiated a recall of certain Solitaire Ti Spacers because they may have a mislabeled lordotic angle of 12degrees when the angle is actually 6 degrees. |
| Root cause | Mixed-up of materials/components |
| Action | Zimmer Biomet sent an Urgent Medical Device Recall Notice letter dated February 26, 2016 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete the enclosed Response Form. For questions call 303-465-8929. |
| Quantity | 10 |
| Distribution | Worldwide Distribution - US Nationwide - one foreign consignee (not Canada). |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081501 | SOLITAIRE ANTERIOR SPINAL SYSTEM Biomet Spine, Jul 2, 2008 |