FDAFDA · Food and drugs·Recall number Z-0828-2015
RESTORIS PST Straight Shell Inserter An impactor is a reusable instrument designed for use by orthopedic surgeons specifically for the purpose of positioning and implanting acetabular cup components during Total Hip Arthroplasty (THA) surgery.
Published December 24, 2014 · Recall initiated: October 7, 2014
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
MAKO has identified the potential that the shell impactors may be damaged intraoperatively.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Mako Surgical Corporation
- Distributor
- Nationwide Distribution including IL, OH, AZ, CO, GA, OK, NC, VA, CT, FL, CA, MA, NY, MI, VA, NH, TX, LA, WA, NJ, CA, RI, ID, TN, IN, WA, PA, and WI.
- Lot
- Part Number: 112710, Lot Numbers: 120027, 120041, 120052, 120074, 120076 and 120075.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.