FDA-Device2017-05-31Class I
10-1398M - SpF-PLUS Implantable Stimulator. Indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels.
EBI Patient Care, Inc.
Hazard
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.
Sold states
Nationwide distribution only.
Affected count
33 units total
Manufactured in
484 Calle E, Guaynabo, PR, United States
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2119-2017Don't want to check this manually?
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