10-1398M - SpF-PLUS Implantable Stimulator. Indicated as a spinal fusion adjunct to increase t...
FDA Recall #Z-2119-2017 — Class I — April 20, 2017
Product Description
10-1398M - SpF-PLUS Implantable Stimulator. Indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels.
Reason for Recall
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.
Recalling Firm
EBI Patient Care, Inc. — Guaynabo, PR
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Devices
Product Quantity
33 units total
Distribution
Nationwide distribution only.
Code Information
Serial Numbers: 410093 410094 410096 410103 410111 410115 410119 410148 410151 410158, and 410171.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated