Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Recalled by Zimmer Biomet, Inc. Due to Lack of adequate validation and controls to ensure...
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 Zimmer Biomet, Inc. directly.
Affected Products
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
Quantity: 4,879 units (2,982 units have been implanted and 537 have been scrapped)
Why Was This Recalled?
Lack of adequate validation and controls to ensure that product cleanliness parameters were consistently met.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Zimmer Biomet, Inc.
Zimmer Biomet, Inc. has 875 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report