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U.S. Department of Health and Human Services

Class 2 Device Recall Exactech GPS Orthopedic stereotaxic instrument

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  Class 2 Device Recall Exactech GPS Orthopedic stereotaxic instrument see related information
Date Initiated by Firm September 22, 2019
Create Date February 11, 2020
Recall Status1 Terminated 3 on July 23, 2020
Recall Number Z-1149-2020
Recall Event ID 84713
510(K)Number K152764  
Product Classification Orthopedic stereotaxic instrument - Product Code OLO
Product Blue Ortho TKA Pro v2.1 software installed on the Exactech GPS system -indicated for stereotaxic surgery in Knee Arthroplasty
Catalog Reference: L00002
Code Information TKA Pro v2.1 software
Recalling Firm/
Manufacturer		 Blue Ortho
6 Allee De Bethleem
Gieres France
For Additional Information Contact SAME
800-3921140
Manufacturer Reason
for Recall		 The navigated values displayed when using the LPI instrumentation are incorrect due to software inconsistencies (wrong data loaded).
FDA Determined
Cause 2		 Software design
Action Blue Ortho issued an Advisory Notice via email on September 22, 2019 stating the reason for recall, health risk and action to take: The issue happens only with the LPI¿ instrumentation. There is no issue with the Truliant¿ instrumentation. Therefore, Blue Ortho ask the user: To use the TKA Pro 2.1 software application with the Truliant¿ instrumentation only, To NOT change the instrumentation once the protocol is started. Do not click on Change instrument nor Change to LPI.If the Truliant¿ instrumentation is not available, the TKA Pro 2.1 software application must not be used. Blue Ortho will deliver a new software version correcting this issue.
Quantity in Commerce 7 units
Distribution AZ, CA, FL, TN Foreign: Italy
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 = BLUE ORTHO
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