Z-0650-2022Class II

Merete PediatrOS RigidTack, REF CP20120, Size 20 mm, Sterile, Rx Only

Name: Z-0650-2022 Merete PediatrOS RigidTack, REF CP20120, Size 20 mm, Sterile, Rx Only
Creator: Merete Medical GmbH
Published: 2022-01-18
License: https://open.fda.gov/license/

Merete GmbH / initiated 2022-01-18 / Terminated / root cause: labeling and UDI

FDA source

Merete Medical GmbH began a recall of Merete PediatrOS RigidTack, REF CP20120, Size 20 mm, Sterile, Rx Only on 2022-01-18. FDA classified it as Class II and gives the reason as "Incorrect marketing label (25 mm) was applied to product size 20 mm". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0650-2022
Classification: Class II
Status: Terminated
Initiated: 2022-01-18
Posted: 2022-02-17
Terminated: 2023-02-16
Recalling firm: Merete GmbH
Product: Merete PediatrOS RigidTack, REF CP20120, Size 20 mm, Sterile, Rx Only
Product code: JDR Staple, Fixation, Bone
Reason for recall: Incorrect marketing label (25 mm) was applied to product size 20 mm.
Root cause tag: labeling and UDI
FDA root 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 [email protected]. 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 [email protected].
Quantity in commerce: 26 units
Distribution: Domestic: Illinois; Foreign: Germany.
Product codes and lots: Model No. CP20120; Lot No. MS2117816; UDI No. (01)04048266150394(17)260706(10)MS2117816

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0650-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0650-2022	Class II	Terminated	Voluntary: Firm initiated	2022-02-23	2022-02-17

Product code JDR

K151762Class IIPediatrOS RigidTack/FlexTackMerete Medical GmbH / cleared 2015-12-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)