FDAFDA · Food and drugs·Recall number Z-1415-2013
12mm x 27mm x 8mm 12mm x 27mm x 9mm 12mm x 27mm x 10mm 12mm x 27mm x 11mm 12mm x 27mm x 12mm 12mm x 27mm x 13mm 12mm x 27mm x 14mm Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple.
Published June 5, 2013 · Recall initiated: February 20, 2013
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
The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Spinal Solutions, LLC
- Distributor
- USA Nationwide Distribution in the states of MS: TX, NV, CA, MD, and WI.
- Lot
- Item # 10227-008 10227-009 10227-010 10227-011 10227-012 10227-013 10227-014
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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