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U.S. Department of Health and Human Services

Class 2 Device Recall stryker Mako Vizadisc Hip Procedure Tracking Kit

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 Class 2 Device Recall stryker Mako Vizadisc Hip Procedure Tracking Kitsee related information
Date Initiated by FirmJuly 24, 2018
Date PostedAugust 24, 2018
Recall Status1 Terminated 3 on October 11, 2022
Recall NumberZ-2925-2018
Recall Event ID 80621
510(K)NumberK121064 
Product Classification Orthopedic stereotaxic instrument - Product Code OLO
ProductStryker Mako Vizadisc Hip Procedure Tracking Kit
Code Information Catalog Number 107130. Lot Numbers 17097K, 17124K, 17129K, 17136K, 17143K, 17103H.  **EXPANSION** Lot Numbers 17007K, 17013K, 17024K, 17035K, 17054K, 16354H.
FEI Number 3005985723
Recalling Firm/
Manufacturer		 Mako Surgical Corporation
2555 Davie Rd Ste 110
Davie FL 33317-7424
For Additional Information ContactMrs. Bethany Hinson
954-628-0598
Manufacturer 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 Determined
Cause 2		Under Investigation by firm
ActionOn 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 Commerce19,906 total devices
DistributionAll 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = OLO
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