EBI Patient Care Recalls SpF-PLUS Implantable Stimulators Due to Cytotoxicity
EBI Patient Care, Inc. is recalling 33 SpF-PLUS Implantable Stimulators due to higher than allowed cytotoxicity levels found during routine process monitoring.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (implantable device with cytotoxicity issues) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for theoretical or unreported harm.
Plain-English summary
EBI Patient Care, Inc. is conducting a medical device field action for the SpF-PLUS Implantable Stimulator (Model 10-1398M). The recall involves 33 units distributed nationwide. The specific serial numbers affected are 410093, 410094, 410096, 410103, 410111, 410115, 410119, 410148, 410151, 410158, and 410171.
The action is being taken because higher than allowed cytotoxicity levels were found during routine process monitoring. The device is indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels.
Consumers and healthcare providers should contact EBI Patient Care, Inc. for further instructions regarding the field action.
The recalled product
- Product
- 10-1398M - SpF-PLUS Implantable Stimulator. Indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels.
- Manufacturer
- EBI Patient Care, Inc.
- Hazard
- Affected units
- 33
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 (1)
- and 410171.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by EBI Patient Care, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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