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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device

EBI Patient Care, Inc.: 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.

Agency Publication Date: May 26, 2017
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Affected Products

Product: 10-1335M - SpF-XL IIB 2/DM Implantable Stimulator. Indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels.

Serial Numbers: 224595 224598 224607 224608 224610 224613 224615 224621 224622 224623 224624 224625 224626 224644 224649 224651 224655 224656 224658 224659 224666, and 224667.

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.

Serial Numbers: 410093 410094 410096 410103 410111 410115 410119 410148 410151 410158, and 410171.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 77089
Status: Resolved
Manufacturer: EBI Patient Care, Inc.
Manufactured In: United States
Units Affected: 2 products (33 units total)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.