Integra® Jarit® 250404Recalls & reported problems
Integra Lifesciences Production Corporation · Integra® Jarit® Orthopedic Mallet, 2 lb. Head Weight · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10381780456001), received between Apr 23, 2026 and Apr 23, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Unraveled Material” (1 report).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Unraveled Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 23, 2026Unraveled Material
A FACILITY REPORTED THAT THE CUSTOMER WAS HITTING A PLATE DURING AN ORTHO PROCEDURE; THAT THE JARIT MALLET 2LB SS 7-9/16 (250404) WAS SCORED AND MARKED WHEN USED; THAT SOME MALLETS WERE CHIPPING; AND THAT METAL SHARDS WERE BEING PULLED OUT OF THE PATIENT'S SURGICAL SITE. NO MEDICAL INTERVENTION WAS REQUIRED, AND NO INJURY, DEATH, OR SURGICAL DELAY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24972775 ↗
Other MALLET devices
- KMEDIC IPN013965Teleflex Incorporated · MALLET3 reports
- TC-PLUS / RT-PLUS 75100394Smith & Nephew, Inc. · MALLET2 reports
- V. Mueller OS1512Steris Corporation · MALLET1 report
- NA 03.010.059Synthes GmbH · MALLET1 report
- Integra® Miltex® 19-790Integra Lifesciences Production 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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