FDAFDA · Food and drugs·Recall number Z-1583-2016
RESTORIS PST RIO Offset Shell Impactor For use by orthopedic surgeons specifically for the purpose of positioning and implanting acetabular cup components during Total Hip Arthroplasty (THA) surgery.
Published May 4, 2016 · Recall initiated: February 23, 2016
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
Potential disassociation of the orientation pin.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Mako Surgical Corporation
- Distributor
- Nationwide Distribution -- AL, CA, CO, CT, FL, GA, IA, ID, IL, IN, LA, MA, MD, MI, MN, MS, NC, NH, NJ, NY, OH, OK, OR, PA, RI, TN, TX, VA, WA, and WI.
- Lot
- Lot #'s 28548, 29130, 29479, 30440, 31801, 31802, and 32145.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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