FDAFDA · Food and drugs·Recall number Z-1276-2013
ExoShape Soft Tissue Fastener 12 mm x 30 mm REF 1101-00-1230. For use in the fixation of ligaments, tendons or soft tissue grafts to bone.
Published May 15, 2013 · Recall initiated: April 4, 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
Expiration date on the patient label and date on the product carton were not the same.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medshape Solutions, INC.
- Distributor
- Nationwide Distribution including the states of CO, FL, GA, IA, MD, MO, OR, TX, VT, VA, and WI.
- Lot
- Lot No. 113011-002
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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