PediatrOS RigidTack recallZ-0650-2022 · Merete Medical GmbH · initiated Jan 18, 2022
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Merete Medical GmbH or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Incorrect marketing label (25 mm) was applied to product size 20 mm.
FDA root cause category: Error in labeling
What the company is doing
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].
Recall details
- Recall number
- Z-0650-2022
- Status
- Terminated
- Initiated by the company
- Jan 18, 2022
- Recalling firm
- Merete Medical GmbH
- Quantity
- 26 units
- Product code
- JDR
- FDA submissions
- K151762
- Distribution
- Domestic: Illinois; Foreign: Germany.
Product description
Merete PediatrOS RigidTack, REF CP20120, Size 20 mm, Sterile, Rx Only
Code information (models, lots, serial numbers)
Model No. CP20120; Lot No. MS2117816; UDI No. (01)04048266150394(17)260706(10)MS2117816
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- PediatrOS™ RigidTack™ 20Merete GmbH · Staple, Fixation, Bone1 recall1 report
Product lines
Other devices under the same FDA submission
1 device cleared under K151762 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- PediatrOS™ RigidTack™ 30Merete GmbH · Staple, Fixation, Bone2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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