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EBI Patient Care, Inc. recalls 10-1398M - SpF-PLUS Implantable Stimulator. Indicated as a spinal fusion adjunct to increase the probability of fusio
Recalled May 31, 2017 · FDA recall Z-2119-2017 · EBI Patient Care
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. · FDA Class I
Units
33 units total
Sold at
Nationwide distribution only.
Description
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.
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(s)
EBI Patient Care, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →