FDAFDA · Food and drugs·Recall number Z-1259-2013
Mercury Spinal System DIA 5.5 x 60mm Straight Rod, Part Number: 60101-060. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
Published May 15, 2013 · Recall initiated: April 17, 2009
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
Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Spinal Elements, Inc
- Distributor
- Distributed in OH and PA.
- Lot
- Lot Number: 080594
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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