Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported April 6, 2016
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
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.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Biomet Spine, LLC recalled 10mm X 12o Solitaire Ti Medium Spacer Solitaire Anterior Spinal System, Model Number 14… - a moderate-severity action.
10mm X 12o Solitaire Ti Medium Spacer Solitaire Anterior Spinal System, Model Number 14… was recalled by Biomet Spine, LLC in April 6, 2016. Reason: Zimmer Biomet Spine initiated a recall of certain Solitaire Ti Spacers because they may have a mislabeled lor…. Check the official notice for the remedy. Verify recall #Z-1253-2016 with the FDA Devices before acting.
The recall
Biomet Spine, LLC issued this moderate-severity FDA Devices recall-Zimmer Biomet Spine initiated a recall of certain Solitaire Ti Spacers because they may have a mislabeled lor….
- Moderate
- severity level
- 10 units
- affected scope
- Class II
- classification
- April 6, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1253-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1253-2016) was formally reported on April 6, 2016, with the manufacturer initiating the action on February 12, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Biomet Spine, LLC is listed as the recalling firm, operating out of Broomfield, CO. Federal records list the affected scope as 10.
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: Worldwide Distribution - US Nationwide - one foreign consignee (not Canada).. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
10
Related Recalls
6
3 from same agency
Product description
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.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1253-2016 |
| Date reported | April 6, 2016 |
| Date initiated | February 12, 2016 |
| Recalling firm | Biomet Spine, LLC |
| Firm location | Broomfield, CO |
| Affected scope | 10 |
| Distribution | Worldwide Distribution - US Nationwide - one foreign consignee (not Canada). |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1253-2016) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Biomet Spine, LLC. Units affected: 10.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on April 6, 2016. Severity: Moderate. Recall number: Z-1253-2016.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US Nationwide - one foreign consignee (not Canada)..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1253-2016) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported April 6, 2016. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.