MAKO RIO Standard System, internal cPCI Card CageP/N: 201337. Intended to assist the surgeon in providing software defined spatial boundaries during orthopedic procedures.
This recall has been terminated (originally issued June 7, 2017).
- Company
- Mako Surgical Corporation
- Recall Initiated
- June 7, 2017
- Terminated
- June 16, 2020
- Recall Number
- Z-2741-2017
- Quantity
- 20
- Firm Location
- Davie, FL
- Official Source
- View on FDA website ↗
Reason for Recall
An intermittent electrical problem that could lead to a loss of system power due to a loose screw connection.
Distribution
Distributed to the states of AZ, CA, CO, CT, FL, GA, ID, LA, MA, MO, MS, NC, OH, PA, TN, TX, & WA.
Lot / Code Info
Lot No. 05212015
Root Cause
Employee error
Action Taken
Customers were sent notices titled "Urgent Medical Device Correction Notification" on 06/12/2017 via UPS Next Day Mail. The firm notifies consignees of the reason for recall and instructs that users of the recalled product be provided the recall notice. Users may continue to use their MAKO system; and, Stryker/MAKO Service personnel will contact users o schedule time to inspect and replace the card cage, if necessary. Also, users are instructed to return the completed Business Reply Form within 5 business days. The completed form can be sent to strykerortho7391@stericycle.com or faxed to 855-544-4807. Any questions can be directed to Clayton Odor at 954-628-0502.