Class 2 Device Recall Bone Fixation Staple

• Date Initiated by Firm: January 18, 2022
• Create Date: February 17, 2022
• Recall Status: Terminated on February 16, 2023
• Recall Number: Z-0650-2022
• Recall Event ID: 89482
• 510(K)Number: K151762
• Product Classification: Staple, fixation, bone - Product Code JDR
• Product: Merete PediatrOS RigidTack, REF CP20120, Size 20 mm, Sterile, Rx Only
• Code Information: Model No. CP20120; Lot No. MS2117816; UDI No. (01)04048266150394(17)260706(10)MS2117816
• Recalling Firm/ Manufacturer: Merete Medical GmbH; Alt-Lankwitz 102; Berlin Germany
• For Additional Information Contact: Paul Munch; 490-30779980181
• Manufacturer Reason for Recall: Incorrect marketing label (25 mm) was applied to product size 20 mm.
• FDA Determined Cause: Error in labeling
• Action: Customers were notified of the recall via phone call on 01/19/2022 and instructed to quarantine any devices from the recalled lot. The recalling firm also informed customers that a written notice was going to be distributed with further instructions. Devices remaining in stock should be separated and quarantined, while those implanted should have patients informed and x-rays conducted to evaluate if the appropriate size was utilized. Additionally, customers were notified via email on 01/27/2022 of the recall in an Urgent Medical Device Recall Notice. The notice identified Lot MS2117816 of PediatrOS RigidTrack staples (Model No. CP20120) as being recalled due to mislabeling. Customers were asked to identify any recalled product in stock, quarantine identified units, and complete the provided Recall Response Form to facilitate the return of affected devices. If product has been implanted already, the firm asks that surgeons verify that the staple is adequately positioned surrounding the epiphyseal cartilage. Completed response forms are to be faxed to +49 (0)30 77 99 80 - 177 or emailed to safety@merete.de. Customers with any questions relating to the recall are encouraged to contact Mr. Paul Munch, Safety Officer, as +49 30 77 99 80 - 181 from 2:00 AM to 10:00 AM Eastern Times Zone, or by phone at +49 151 1881 6304 outside of office hours. He is also available by email at safety@merete.de.
• Quantity in Commerce: 26 units
• Distribution: Domestic: Illinois; Foreign: Germany.
• 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 = JDR