Z-2741-2017Class II

MAKO RIO Standard System, internal cPCI Card CageP/N: 201337. Intended to assist the surgeon in providing...

Name: Z-2741-2017 MAKO RIO Standard System, internal cPCI Card CageP/N: 201337. Intended to assist the surgeon in providing...
Creator: Mako Surgical Corporation
Published: 2017-06-07
License: https://open.fda.gov/license/

Mako Surgical Corp. / initiated 2017-06-07 / Terminated / root cause: manufacturing process

FDA source

Mako Surgical Corporation began a recall of MAKO RIO Standard System, internal cPCI Card CageP/N: 201337. Intended to assist the surgeon in providing software defined spatial boundaries during orthopedic... on 2017-06-07. FDA classified it as Class II and gives the reason as "An intermittent electrical problem that could lead to a loss of system power due to a loose screw connection". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2741-2017
Classification: Class II
Status: Terminated
Initiated: 2017-06-07
Posted: 2017-07-18
Terminated: 2020-06-16
Recalling firm: Mako Surgical Corp.
Product: MAKO RIO Standard System, internal cPCI Card CageP/N: 201337. Intended to assist the surgeon in providing software defined spatial boundaries during orthopedic procedures.
Product code: OLO Orthopedic Stereotaxic Instrument
Reason for recall: An intermittent electrical problem that could lead to a loss of system power due to a loose screw connection.
Root cause tag: manufacturing process
FDA root cause: Employee error
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.
Quantity in commerce: 20
Distribution: Distributed to the states of AZ, CA, CO, CT, FL, GA, ID, LA, MA, MO, MS, NC, OH, PA, TN, TX, & WA.
Product codes and lots: Lot No. 05212015

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2741-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2741-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-26	2017-07-18

Product code OLO

K112507Class IIRestoris Partial Knee Application (Pka), Rio Standard SystemMako Surgical Corporation / cleared 2012-03-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)