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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Mako Vizadisc Knee Procedure Tracking Kit

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  Class 2 Device Recall Stryker Mako Vizadisc Knee Procedure Tracking Kit see related information
Date Initiated by Firm July 24, 2018
Date Posted August 24, 2018
Recall Status1 Terminated 3 on October 11, 2022
Recall Number Z-2924-2018
Recall Event ID 80621
510(K)Number K112507  
Product Classification Orthopedic stereotaxic instrument - Product Code OLO
Product Stryker Mako Vizadisc Knee Procedure Tracking Kit
Code Information Catalog Number 107120. Lot Numbers 17097K, 17124K, 17129K, 17136K, 17143K, 17103H.  **EXPANSION** Lot Numbers 17007K, 17013K, 17024K, 17035K, 17054K, 16354H.
Recalling Firm/
Manufacturer		 Mako Surgical Corporation
2555 Davie Rd Ste 110
Davie FL 33317-7424
For Additional Information Contact Mrs. 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
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.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = OLO and Original Applicant = MAKO SURGICAL CORPORATION
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