Integra® Miltex® 19-790Recalls & reported problems
Integra Lifesciences Production Corporation · Integra® Miltex® Gerzog Mallet 7-1/2", Head: Weight 8oz. · Class 1
All models of Integra Miltex (21)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10381780420941), received between Aug 3, 2026 and Aug 3, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Material Twisted/Bent” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Material Twisted/Bent1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 3, 2026Material Twisted/Bent
The surgeon reported that the GERZOG MALLET 7-1/2 LEAD (19-790) had pitting occurring on both ends upon using it during SI Bone Fusion Surgery. Both striking ends of the mallet appeared to be soft and able to make indentations with a fingernail. Prior to use, the surface of the mallet was smooth and free of any defects. The instrument was in direct contact with procedural pins utilized to make space in the patient's bone for the fusion device to be implanted. It is possible that part of the mallet came in contact with the patient within the surgical site. There is also a concern regarding the risk of flaking/particles from the mallet, which could have entered the surgical site, posing a potential risk for infection or retained particles. Additional information provided states, 'particles were not noticed on the surface, would not be able to see beyond surface level deeper into the surgical incision. Looking at the mallet, there appear to be areas with "chunks" missing, as well as surface indentations visible. The patient continues to have pain and denies any symptoms of infection.' There was no injury, death, or surgical delay reported during the procedure.
Patient problems: Foreign Body In Patient
MAUDE report 50114268 ↗
Other MALLET devices
- KMEDIC IPN013965Teleflex Incorporated · MALLET3 reports
- TC-PLUS / RT-PLUS 75100394Smith & Nephew, Inc. · MALLET2 reports
- NA 03.010.059Synthes GmbH · 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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