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/ Manufacturer |
Zimmer Biomet, Inc. 1800 W Center St Warsaw IN 46580-2304
|
For Additional Information Contact |
Mr. Kevin W. Escapule 574-267-6131
|
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
|