Z-2925-2018Class II

Stryker Mako Vizadisc Hip Procedure Tracking Kit

Name: Z-2925-2018 Stryker Mako Vizadisc Hip Procedure Tracking Kit
Creator: Mako Surgical Corporation
Published: 2018-07-24
License: https://open.fda.gov/license/

Mako Surgical Corp. / initiated 2018-07-24 / Terminated

FDA source

Mako Surgical Corporation began a recall of Stryker Mako Vizadisc Hip Procedure Tracking Kit on 2018-07-24. FDA classified it as Class II and gives the reason as "Specific lots of the Vizadisc Knee Procedure Tracking Kit and Vizadisc Hip Procedure Tracking Kit have the potential to be damaged on the Vizadisc reflective material causing an inability to be detected by the camera". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2925-2018
Classification: Class II
Status: Terminated
Initiated: 2018-07-24
Posted: 2018-08-24
Terminated: 2022-10-11
Recalling firm: Mako Surgical Corp.
Product: Stryker Mako Vizadisc Hip Procedure Tracking Kit
Product code: OLO Orthopedic Stereotaxic Instrument
Reason for recall: Specific lots of the Vizadisc Knee Procedure Tracking Kit and Vizadisc Hip Procedure Tracking Kit have the potential to be damaged on the Vizadisc reflective material causing an inability to be detected by the camera.
FDA root cause: Under Investigation by firm
Action: On about 07/24/2018, Stryker sent letters to all their consignees via URGENT MEDICAL DEVICE REMOVAL letter. Instructions for risk mitigation included to perform a visual inspection the discs during pre-surgery setup as the defect can be recognized due to apparent discoloration and in the event that a Vizadisc is damaged, risk may be mitigated by testing the Vizadiscs by attaching them to the probes and arrays during pre-surgery setup, as per Stryker's recommendations in "Surgical Technique Guide." This provides an opportunity for the user to show each instrument to the camera after assembly to confirm that all discs are detectable. Additional instructions included to inform all individuals of the recall within the organization, complete and return the enclosed Recall Notification Business Reply Form, and arrange for to return all affected devices to Stryker in Mahwah, NJ. On about 11/27/2018, Stryker initiated an expansion of the recall and notified customers via "UPDATE URGENT MEDICAL DEVICE REMOVAL" letter. Instructions are the same as in the original notification letter.
Quantity in commerce: 19,906 total devices
Distribution: All devices were distributed in the US in the following states: AK, AL, AR, AZ, CA, CO, CT, FL, IA, ID, KS, KY, LA, MA, MD, MI, MN, MO, NE, NC, NH, NJ, NY, NV, OH, PA, RI, SC, SD, TN. TX, UT, VA, WA, WI.
Product codes and lots: Catalog Number 107130. Lot Numbers 17097K, 17124K, 17129K, 17136K, 17143K, 17103H. **EXPANSION** Lot Numbers 17007K, 17013K, 17024K, 17035K, 17054K, 16354H.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2925-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2924-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-05	2018-08-24
Z-2925-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-05	2018-08-24

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)