FDAFDA · Food and drugs·Recall number Z-2119-2017
10-1398M - SpF-PLUS Implantable Stimulator. Indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels.
Published May 31, 2017 · Recall initiated: April 20, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- EBI Patient Care, Inc.
- Distributor
- Nationwide distribution only.
- Lot
- Serial Numbers: 410093 410094 410096 410103 410111 410115 410119 410148 410151 410158, and 410171.
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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