Z-1193-2017Class II

Stryker Restoris RIO Reamer Handle, Offset, Mako Rx only

Name: Z-1193-2017 Stryker Restoris RIO Reamer Handle, Offset, Mako Rx only
Creator: Mako Surgical Corporation
Published: 2016-09-29
License: https://open.fda.gov/license/

Mako Surgical Corp. / initiated 2016-09-29 / Terminated

FDA source

Mako Surgical Corporation began a recall of Stryker Restoris RIO Reamer Handle, Offset, Mako Rx only Product Usage: The handle is used to hold surgical components during acetabular reaming in MAKO Total... on 2016-09-29. FDA classified it as Class II and gives the reason as "Failure of the Offset Cup Reamer Handle not engaging its mating components". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1193-2017
Classification: Class II
Status: Terminated
Initiated: 2016-09-29
Posted: 2017-02-11
Terminated: 2019-08-06
Recalling firm: Mako Surgical Corp.
Product: Stryker Restoris RIO Reamer Handle, Offset, Mako Rx only Product Usage: The handle is used to hold surgical components during acetabular reaming in MAKO Total Hip procedures.
Product code: OLO Orthopedic Stereotaxic Instrument
Reason for recall: Failure of the Offset Cup Reamer Handle not engaging its mating components.
FDA root cause: Component change control
Action: Customers were sent a recall notificaiton letter, dated 10/17/2016, addressing the reason for recall and the appropriate actions that should be taken by customers. Consignees are instructed to return any recalled product on hand to Stryker C/O Stericycle, 2670 Executive Dr. Suite A, Indianapolis, IN 46241, Attn RA 2016-083, RA 2016-119 - Event 8811. Consignees are also instructed to inform their users of this recall and forward the notice to affected individuals. A Business Reply Form was provided and is to be completed within 5 business days of receipt by consignees. Completed business reply forms are to be faxed to 855-620-5693 or emailed to [email protected].
Quantity in commerce: 595 units
Distribution: Worldwide Distribution - US Nationwide in the states of AL, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NJ, NM, NY, OH, OK, OR, PA, RI, TN, TX, UT, VA, WA, WI, WV, & WY and the countries of Italy, Germany, Australia, China, Europe, Hong Kong, South Africa, Germany, Thailand & Singapore.
Product codes and lots: All lots recalled, Catalog No. 207080.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1193-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1193-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-22	2017-02-10

Product code OLO

K121064Class IIMakoplasty Total Hip Application, Rio Standard SystemMako Surgical Corporation / cleared 2012-06-06

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)