FDAFDA · Food and drugs·Recall number Z-2741-2017
MAKO RIO Standard System, internal cPCI Card CageP/N: 201337. Intended to assist the surgeon in providing software defined spatial boundaries during orthopedic procedures.
Published July 26, 2017 · Recall initiated: June 7, 2017
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
An intermittent electrical problem that could lead to a loss of system power due to a loose screw connection.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Mako Surgical Corporation
- Distributor
- Distributed to the states of AZ, CA, CO, CT, FL, GA, ID, LA, MA, MO, MS, NC, OH, PA, TN, TX, & WA.
- Lot
- Lot No. 05212015
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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