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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker USB Converter, Polaris Spectra Camera for MAKO RoboticArm Assisted Surgery System

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 Class 2 Device Recall Stryker USB Converter, Polaris Spectra Camera for MAKO RoboticArm Assisted Surgery Systemsee related information
Date Initiated by FirmAugust 08, 2022
Create DateSeptember 09, 2022
Recall Status1 Terminated 3 on May 22, 2026
Recall NumberZ-1735-2022
Recall Event ID 90727
510(K)NumberK121064 
Product Classification Orthopedic stereotaxic instrument - Product Code OLO
ProductStryker USB Converter, Polaris Spectra Camera, Catalog #201148, a component of the Mako Robotic-Arm Assisted Surgery System.
Code Information Lot #22041607, UDI-DI (GTIN) 07613327407280.
FEI Number 3005985723
Recalling Firm/
Manufacturer		 Mako Surgical Corporation
3365 Enterprise Ave
Weston FL 33331-3524
Manufacturer Reason
for Recall		Certain units have the potential to exhibit infant failures whereby units either arrive non-functional, have the potential to become non-functional, or flash an error light while in use.
FDA Determined
Cause 2		Under Investigation by firm
ActionStryker issued an "URGENT MEDICAL DEVICE CORRECTION" letter dated 8/8/2022 on the same date notifying their customers of a correction for the Mako System's USB Converter, Polaris Spectra Camera. The letter provided the issue, potential hazard, potential harm, risk mitigation, and actions needed. The actions included informing users of the medical device correction and forwarding the letter to all individuals who need to be aware within their organization. Complete and sign the enclosed Business Reply Form and email to SO_M_PRODUCT_FIELD_ACTION_RESPONSE@stryker.com within 5 days. The customer was informed Stryker will replace non-conforming USB Converter, Polaris Cameras, within the scope of the notification with qualified parts unaffected by the nonconformance. If you have any questions, please email:bradley.curtis@stryker.com.
Quantity in Commerce2
DistributionUS Distribution was made to IL and AZ.
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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