CLASS II Device recall · Reported 6 Apr 2016 · FDA Enforcement Report
X 12o Solitaire Ti Medium Spacer Solitaire Anterior Spinal System recalled
Biomet Spine is recalling X 12o Solitaire Ti Medium Spacer Solitaire Anterior Spinal System, distributed nationwide in the US. The recall was initiated on 12 Feb 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1253-2016
- FDA event ID
- 73402
- Recalling firm
- Biomet Spine, Broomfield, CO
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Feb 2016
- FDA classified
- 25 Mar 2016
- Reported
- 6 Apr 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Spinal Implants
Timeline
| 12 Feb 2016 | Recall initiated by company | |
| 25 Mar 2016 | Classified by FDA | +42 days |
| 6 Apr 2016 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
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 the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Additionally, the SOLITAIRETM ANTERIOR SPINAL SYSTEM is indicated for use in the thoracolumbar spine (i.e., T10 to L5) to replace a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The SolitaireTM System is also indicated for treating fractures of the thoracic and lumbar spine. The SolitaireTM System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period.
Where it was distributed
Worldwide Distribution - US Nationwide - one foreign consignee (not Canada).
Questions about this recall
Is X 12o Solitaire Ti Medium Spacer Solitaire Anterior Spinal System recalled?
Yes. Biomet Spine recalled X 12o Solitaire Ti Medium Spacer Solitaire Anterior Spinal System on 12 Feb 2016. The recall is Class II and its status is Terminated. Recall number Z-1253-2016.
Why was it recalled?
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.
Which lots are affected?
P/N1400-1230 from Lot#2350871 from either loose inventory or Kit 555000162, Date of Manufacture: April 16, 2013
Where was it sold?
Worldwide Distribution - US Nationwide - one foreign consignee (not Canada).
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
| Device | CLASS II | Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: ENT recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: A-P PACK recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |