PediatrOS RigidTackRecalls & reported problems across all models
Merete GmbH · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls
- 1
We found 2 models of PediatrOS RigidTack by Merete GmbH in the FDA's device registry (GUDID). Together they are named in 3 adverse event reports in the FDA's MAUDE database, received between Aug 2, 2018 and May 4, 2022 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).
1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
PediatrOS RigidTack recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jan 18, 2022Terminated
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 PediatrOS RigidTack problems
Device problems
- Device Dislodged or Dislocated2
- Device Markings/Labelling Problem1
- Material Deformation1
- Material Twisted/Bent1
- Nonstandard Device1
Patient problems
- Failure of Implant1
- Insufficient Information1
- No Known Impact Or Consequence To Patient1
PediatrOS RigidTack models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- PediatrOS™ RigidTack™ 20Staple, Fixation, Bone1 recall1 report
- PediatrOS™ RigidTack™ 30Staple, Fixation, Bone2 reports
Recent PediatrOS RigidTack adverse event reports
The 3 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryMay 4, 2022Device Dislodged or Dislocated; Material Twisted/Bent
THE PATIENT HAS BEEN IMPLANTED WITH RIGIDTACK STAPLES TO SLOW DOWN HIS GROWTH. TO TREAT A GENU VARUM THE STAPLES ON ONE SIDE OF THE LEG HAVE BEEN REMOVED. BY THAT THE STAPLES STARTED TO BEND AND DISLOCATE. HENCE THAT THE STAPLES HAVE BEEN REMOVED.
Patient problems: Failure of Implant
MAUDE report 14274409 ↗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 ↗InjuryAug 2, 2018Device Dislodged or Dislocated; Material Deformation
THE PATIENT HAS BEEN IMPLANTED WITH RIGIDTACK STAPLES TO SLOW DOWN HIS GROWTH. TO TREAT A GENU VARUM THE STAPLES ON ONE SIDE OF THE LEG HAVE BEEN REMOVED. BY THAT THE STAPLES STARTED TO BEND AND DISLOCATE. HENCE THAT THE STAPLES HAVE BEEN REMOVED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7742622 ↗
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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