Spine Wave Access Kit Recalled for Mislabeled Probe Dimensions
Spine Wave, Inc. is recalling 121 Spine Wave Access Kits because the outer carton mislabels the monopolar probe dimensions. The probe is listed as 200 x 1.5mm instead of the correct 280 x 1.5mm.
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 minor labeling error regarding product dimensions. No injuries, illnesses, or adverse health consequences are reported in the source text, fitting the criteria for a moderate severity score.
Plain-English summary
Spine Wave, Inc. is recalling 121 units of the Spine Wave Access Kit, Catalog Number 10-1530. The recall is due to a labeling error on the outer carton, which incorrectly lists the Rhythmlink Monopolar Stimulating Probe as 200 x 1.5mm when the actual dimensions are 280 x 1.5mm. The kit also includes a Disposable Dilator Set.
The affected products were distributed nationwide in California, Florida, Georgia, Louisiana, Massachusetts, Maryland, Michigan, Missouri, North Carolina, New Hampshire, Ohio, Oregon, Pennsylvania, Texas, and Virginia. The specific lot codes involved are 092514Z, 120814A, 011415H, and 022415F.
The Spine Wave Access Kit is a medical device used for the stimulation of cranial and peripheral motor nerves during surgery. Users should verify the dimensions of the probe against the actual device rather than relying solely on the outer carton labeling. This recall is classified as Class II by the FDA.
The recalled product
- Product
- Spine Wave Access Kit, Catalog Number 10-1530 Package contents: RLSP494-Rhythmlink Monopolar Stimulating Probe and 10-1525 Disposable Dilator Set. Product Usage: The Spine Wave Access Kit is comprised of a sterile monopolar stimulating probe (individually packaged by…
- Manufacturer
- Spine Wave, Inc.
- Hazard
- Affected units
- 121
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)
- Lot Codes: 092514Z
- 120814A
- 011415H and 022415F
Distribution
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