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U.S. Department of Health and Human Services

Class 2 Device Recall Rim Plate, 10Hole, Left, PRS RX System

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  Class 2 Device Recall Rim Plate, 10Hole, Left, PRS RX System see related information
Date Initiated by Firm May 09, 2019
Create Date June 04, 2019
Recall Status1 Open3, Classified
Recall Number Z-1718-2019
Recall Event ID 82796
510(K)Number K063166  
Product Classification Plate, fixation, bone - Product Code HRS
Product Rim Plate, 10-Hole, Left, PRS RX System. Titanium, implantable - Product Usage: The implant temporarily stabilizes bone segments until bony consolidation has taken place. After this, the implant has no more use and can be removed.
Code Information Model Number: 21206-10; Lot Code: 26/F42778
Recalling Firm/
I.T.S. GmbH
Autal 28
Lasnitzhohe Austria
Manufacturer Reason
for Recall
The titanium implant has the wrong article number laser marked on it.
FDA Determined
Cause 2
Labeling mix-ups
Action I.T.S. GmbH notified international consignees initially on about 05/09/2019, via an updated "Urgent Notice MEDICAL DEVICE RECALL" letter, and US customers were notified to quarantine affected devices. On about 05/13/2019, US customers were notified via an updated "Urgent Notice MEDICAL DEVICE RECALL" letter. Customers were instructed to immediately review their inventory to identify and remove all affected products listed above in a manner that ensures the affected products will not be used, review, complete, sign and return the attached reply form and send it back within 5 business days of receipt of the notification, return any affected product as soon as possible within 30 business days and include a copy of this notification, and forward the recall notification to any appropriate parties that need to be informed about this recall. lf any of the affected products have been forwarded to another facility, customers were instructed to contact that facility to arrange return and provide them with a copy of the recall notification. A copy of this letter was instructed to be kept.
Quantity in Commerce 65 devices
Distribution Worldwide distribution - US nationwide distribution in the states of Florida and Puerto Rico, and countries of Austria, Netherlands, Slovenia, South Africa, Switzerland.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = HRS and Original Applicant = I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH