EBI Patient Care Recalls Spinal Fusion Stimulators Due to Cytotoxicity
EBI Patient Care is recalling 33 SpF-XL IIB implantable stimulators because routine monitoring found higher than allowed cytotoxicity levels.
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 medical device with a chemical hazard (cytotoxicity) where no specific injuries or illnesses are reported in the source text, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
EBI Patient Care, Inc. is conducting a medical device field action for the SpF PLUS-Mini and SpF XL IIB Implantable Spinal Fusion Stimulator products. The recall involves 33 units of the 10-1335M - SpF-XL IIB 2/DM Implantable Stimulator, which is indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels.
The action was taken due to higher than allowed cytotoxicity levels found during routine process monitoring with the product. The affected units were distributed nationwide.
Patients who have received these devices should contact their healthcare provider for further instructions. The specific serial numbers for the affected units are listed in the official recall documentation.
The recalled product
- Product
- 10-1335M - SpF-XL IIB 2/DM 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 224667.
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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