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U.S. Department of Health and Human Services

Class 2 Device Recall ROSA 1.0.2 (Spine application)

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 Class 2 Device Recall ROSA 1.0.2 (Spine application)see related information
Date Initiated by FirmMay 01, 2017
Create DateFebruary 16, 2018
Recall Status1 Terminated 3 on July 13, 2020
Recall NumberZ-0639-2018
Recall Event ID 78944
510(K)NumberK151511 
Product Classification Orthopedic stereotaxic instrument - Product Code OLO
ProductROSA Spine 1.0.2 Stereotaxic instrument Computer-assisted surgical device. Intended for the spatial positioning and orientation of instrument holders to be used by surgeons.
Code Information SP16008
Recalling Firm/
Manufacturer		 Zimmer Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
Manufacturer Reason
for Recall		Robot arm being sent to the wrong position
FDA Determined
Cause 2		Software design
ActionUrgent Medical Device Recall (Correction) notices were sent to customers. The letter provided to hospital risk managers and surgeons identified the issue and their responsibilities. These responsibilities included: - Stop using the micromovement function in isocentric mode during Brain Surgery with ROSA Brain 3.0 device. -Reviewing the notification to ensure comprehension of the steps required to be taken prior to the permanent correction that will be implemented on site by a service engineer. - Completing and returning Attachment 1 (Certificate of Acknowledgement) to the e-mail address provided. The firm has prepared a software correction that will be deployed and implemented on site by a MEDTECH representative.
Quantity in Commerce1
DistributionDistributed to CA, DC, FL, IL, KY, MA, MN, NC, NY, OH, and PA.
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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