FDAFDA · Food and drugs·Recall number Z-1664-2013
BASE, S-LIFT Instrument Case Product Usage: System cases are designed to hold and secure all instrumentation to be used with a surgical system. Case and caddy components are used to contain implants intended for intervertebral body fusion and fixation of the spine.
Published July 10, 2013 · Recall initiated: May 17, 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 S-LIFT Instrument Case contained a bracket with peeling nylon coating.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- SpineFrontier, Inc.
- Distributor
- USA Nationwide including the states of: FL, CO, Wash DC, VA, KS, TX, OH, TN, OK, CA, IL, MO, and MN.
- Lot
- Lot/Serial Numbers: 7201.007 and 7201.007-1
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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