Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
10-1398M - SpF-PLUS Implantable Stimulator. Indicated as a spinal fusion Recalled by EBI Patient Care, Inc. Due to Zimmer Biomet is conducting a medical device field...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact EBI Patient Care, Inc. directly.
Affected Products
10-1398M - SpF-PLUS Implantable Stimulator. Indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels.
Quantity: 33 units total
Why Was This Recalled?
Zimmer Biomet is conducting a medical device field action for the SpF PLUS-Mini and SpF XL IIB Implantable Spinal Fusion Stimulator products due to higher than allowed cytotoxicity levels found during routine process monitoring with the product.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About EBI Patient Care, Inc.
EBI Patient Care, Inc. has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report