PediatrOS™ RigidTack™ 20Recalls & reported problems
Merete GmbH · TiAl6V4 ELI sterile · Class 2 · Implant
All models of PediatrOS RigidTack (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04048266150394), received between Jan 28, 2022 and Jan 28, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Markings/Labelling Problem” (1 report).
1 FDA recall record name this device's identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Recalls naming this device
- Jan 18, 2022Class IITerminated
Incorrect marketing label (25 mm) was applied to product size 20 mm.
Z-0650-2022 · Root cause: Error in labeling · Recall details · FDA record ↗
Most reported problems
Device problems
- Device Markings/Labelling Problem1
- Nonstandard Device1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 28, 2022Nonstandard Device; Device Markings/Labelling Problem
MERETE WAS INFORMED BY A DISTRIBUTOR IN (B)(6) THAT DISCREPANCIES BETWEEN PRODUCT LABELING AND A MARKETING LABEL OCCURRED. THE DISCREPANCY IS EVIDENT AS THE PRODUCT LABEL, CLEARLY INDICATING A CP20120/ LOT: MS2117816, WHICH IS A SIZE 20 MM STAPLE, BUT THE MARKETING LABEL INDICATING THE DEVICE AS A SIZE 25 MM STAPLE.
Patient problems: Insufficient Information
MAUDE report 13384431 ↗
Other Staple, Fixation, Bone devices
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- GII QUICKANCHOR ETHIBOND 212034Medos International Sàrl · STAPLE, FIXATION, BONE98 reports
- GII QUICKANCHOR ORTHOCORD 222983Medos International Sàrl · STAPLE, FIXATION, BONE94 reports
- Speed SE-0910Synthes GmbH · Staple, Fixation, Bone1 recall24 reports
- Speed Shift SE-2020-10Synthes GmbH · Staple, Fixation, Bone1 recall10 reports
- Lapiplasty SpeedPlate SK50Treace Medical Concepts, Inc. · Staple, Fixation, Bone59 reports
- Speed SE-1512Synthes GmbH · Staple, Fixation, Bone1 recall6 reports
- LUPINE ORTHOCORD 210709Depuy Mitek, LLC · STAPLE, FIXATION, BONE56 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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