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U.S. Department of Health and Human Services

Class 2 Device Recall ROSA Surgical Device 2.5.8

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  Class 2 Device Recall ROSA Surgical Device 2.5.8 see related information
Date Initiated by Firm February 14, 2014
Create Date November 16, 2017
Recall Status1 Terminated 3 on September 16, 2020
Recall Number Z-0102-2018
Recall Event ID 78372
510(K)Number K101791  K092239  
Product Classification Neurological stereotaxic Instrument - Product Code HAW
Product ROSA Surgical Device 2.5.8.

It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide
Code Information Serial #s; RO10009, RO10011, RO10014, and RO13023 
Recalling Firm/
Zimmer Biomet, Inc.
1800 W Center St
Warsaw IN 46580-2304
For Additional Information Contact Mr. Kevin W. Escapule
Manufacturer Reason
for Recall
An undetected shift between the information displayed in the navigation software and the actual patient anatomy
FDA Determined
Cause 2
Error in labeling
Action There were 4 units imported into the US and all have been corrected.
Quantity in Commerce 21 (4 US and 17 OUS)
Distribution OH, MI and TX
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 = HAW and Original Applicant = MEDTECH S.A.
510(K)s with Product Code = HAW and Original Applicant = MEDTECH SAS