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EBI Patient Care Recalls
2 recalls on record · May 31, 2017 to May 31, 2017 · Medical Devices
May 31, 2017Medical DevicesFDA
EBI Patient Care, Inc. recalls 10-1398M - SpF-PLUS Implantable Stimulator. Indicated as a spinal fusion adjunct to increase the probability of fusio
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.
May 31, 2017Medical DevicesFDA
EBI Patient Care, Inc. recalls 10-1335M - SpF-XL IIB 2/DM Implantable Stimulator. Indicated as a spinal fusion adjunct to increase the probability o
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.