KMEDIC IPN013965Recalls & reported problems
Teleflex Incorporated · ORTHOPEDIC MALLET 2 LB/ 1 LB · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 24026704272222), received between Aug 19, 2021 and Mar 1, 2022 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (2 reports).
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 16, 2026.
Most reported problems
Device problems
- Break2
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 1, 2022Break; Break
INSTRUMENT BROKE DURING PROCEDURE WHILE BEING USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13632755 ↗MalfunctionOct 4, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
NO INJURIES, PATIENT UNHARMED, HEAD SHEARED OFF AT JUNCTION OF HANDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12569041 ↗MalfunctionAug 19, 2021Break; Break
INSTRUMENT DAMAGED DUE TO POOR QUALITY. MALLET HEADS HAVE DEFORMED SHAPE. FURTHER 2 OF THESE HAVE ACTUALLY BROKEN FROM THE STEM, ONE HAPPENED IN THEATRE WHICH IS VERY DANGEROUS TO STAFF AND PATIENT IF ACTUALLY IT HIT SOMEONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12342100 ↗
Other MALLET devices
- TC-PLUS / RT-PLUS 75100394Smith & Nephew, Inc. · MALLET2 reports
- NA 03.010.059Synthes GmbH · MALLET1 report
- Integra® Miltex® 19-790Integra Lifesciences Production Corporation · MALLET1 report
- Integra® Jarit® 250404Integra Lifesciences Production Corporation · MALLET1 report
- V. Mueller OS1512Steris Corporation · MALLET1 report
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
- 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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