MAKO RIO Standard System, internal cPCI Card CageP/N: 201337. Intended to assist the surgeon in providing software defined spatial boundaries during orthopedic procedures.
Recall
- Recall Number
- Z-2741-2017
- Event Number
- 77553
- Firm
- Mako Surgical Corporation
- FEI Number
- 3005985723
- Product Code
- OLO
- Status
- Terminated
- Root Cause
- Employee error
- Initiated
- June 7, 2017
- Terminated
- June 16, 2020
- Address
- 2555 Davie Rd, Ste 110, Davie, FL, 33317-7424
Description
MAKO RIO Standard System, internal cPCI Card CageP/N: 201337. Intended to assist the surgeon in providing software defined spatial boundaries during orthopedic procedures.
An intermittent electrical problem that could lead to a loss of system power due to a loose screw connection.
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 [email protected] or faxed to 855-544-4807. Any questions can be directed to Clayton Odor at 954-628-0502.
Distributed to the states of AZ, CA, CO, CT, FL, GA, ID, LA, MA, MO, MS, NC, OH, PA, TN, TX, & WA.
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