Biomet Spine Recalls Solitaire Ti Spacers Due to Mislabeled Lordotic Angle
Biomet Spine is recalling specific Solitaire Ti Spacers because they are mislabeled as having a 12-degree lordotic angle when the actual angle is 6 degrees.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error regarding the device's angle. No injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity recall involving minor labeling errors or low-risk issues.
Plain-English summary
Biomet Spine, LLC has initiated a recall of 10 units of the 10mm X 12o Solitaire Ti Medium Spacer, Model Number 1400-1230, from the Solitaire Anterior Spinal System. The recall was initiated because the devices may have a mislabeled lordotic angle of 12 degrees when the actual angle is 6 degrees.
The affected units are from Lot #2350871, manufactured on April 16, 2013. These spacers were distributed worldwide, including nationwide in the United States and to one foreign consignee. The Solitaire Spinal System is designed for use with autograft for stand-alone intervertebral body fusion in the lumbar spine or for replacing diseased vertebral bodies in the thoracolumbar spine.
Healthcare providers and patients should verify the lot number and model number of any implanted or stored devices against the recall information. If a device matches the recalled lot and model, it should be removed from use or returned to the manufacturer according to Biomet Spine's instructions.
The recalled product
- Product
- 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…
- Manufacturer
- Biomet Spine, LLC
- Category
- Medical Device — Spinal Implant
- Hazard
- Affected units
- 10
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- P/N1400-1230 from Lot#2350871 from either loose inventory or Kit 555000162
- Date of Manufacture: April 16
- 2013
Distribution
Distributed nationwide across the United States.
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