MAKO RIO Standard System, internal cPCI Card CageP/N: 201337. Intended to assist the surgeon in providing software defined spatial boundaries during orthopedic procedures.
FDA Recall Z-2741-2017 · Posted None
Recalling FirmMako Surgical Corporation
Recall StatusTerminated
Product CodeOLO
Date Initiated2017-06-07
Date Terminated2020-06-16
Product Quantity20
Reason for Recall
An intermittent electrical problem that could lead to a loss of system power due to a loose screw connection.
Firm Action
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.
Root Cause
Employee error
Distribution Pattern
Distributed to the states of AZ, CA, CO, CT, FL, GA, ID, LA, MA, MO, MS, NC, OH, PA, TN, TX, & WA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.