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

• Date Initiated by Firm: May 09, 2019
• Create Date: June 04, 2019
• Recall Status: Open, 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/ Manufacturer: 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: 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