Integra MiltexRecalls & reported problems across all models
Integra Lifesciences Production Corporation · 21 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one Integra Miltex model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 69
- Deaths reported
- 0
- Injuries reported
- 27
- Recalls
- 2
We found 21 models of Integra Miltex by Integra Lifesciences Production Corporation in the FDA's device registry (GUDID). Together they are named in 69 adverse event reports in the FDA's MAUDE database, received between Feb 23, 2022 and Aug 17, 2026 — classified as 27 injuries, 41 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (29 reports).
2 FDA recall records name at least one of these models by its device identifier, 2 still open.
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
Reports received per month, all models
Integra Miltex 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.
- Dec 19, 2024Open, Classified
During the assembly of the cartridge to its connecting body part, the valve may open prematurely resulting in partial or complete emptying of the cartridge before its intended use.
Z-1104-2025 · Root cause: Device Design · Recall details · FDA record ↗
- Dec 19, 2024Open, Classified
During the assembly of the cartridge to its connecting body part, the valve may open prematurely resulting in partial or complete emptying of the cartridge before its intended use.
Z-1103-2025 · Root cause: Device Design · Recall details · FDA record ↗
Most reported Integra Miltex problems
Device problems
- Leak/Splash29
- Break11
- Explosion5
- Failure to Osseointegrate3
- Loss of Osseointegration3
- Material Fragmentation3
- Mechanical Problem3
- Physical Resistance/Sticking3
Patient problems
- No Clinical Signs, Symptoms or Conditions40
- Caustic/Chemical Burns6
- Failure of Implant6
- Burn(s)3
- Cryogenic Burn3
- Hemorrhage/Blood Loss/Bleeding3
- Laceration(s)3
- Inflammation2
Integra Miltex models
21 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Integra® Miltex® 33517UNIT, CRYOSURGICAL, ACCESSORIES1 recall17 reports
- Integra® Miltex® 33516UNIT, CRYOSURGICAL, ACCESSORIES1 recall4 reports
- Integra® Miltex® 33510UNIT, CRYOSURGICAL, ACCESSORIES15 reports
- Integra® Miltex® 4-115BLADE, SCALPEL6 reports
- Integra® Miltex® 33518UNIT, CRYOSURGICAL, ACCESSORIES4 reports
- Integra® Miltex® 26-332RONGEUR, MANUAL3 reports
- Integra® Miltex® V930-965TENACULUM, UTERINE3 reports
- Integra® Miltex® 33-100SCALPEL, ONE-PIECE2 reports
- Integra® Miltex® 22-302ELEVATOR, ENT2 reports
- Integra® Miltex® 5-306TCSCISSORS, OPHTHALMIC2 reports
- Integra® Miltex® 26-2000DRILLS, BURRS, TREPHINES & ACCESSORIES (MANUAL)1 report
- Integra® Miltex® 24652CLAMP, VASCULAR1 report
- Integra® Miltex® 72-30RETAINER, MATRIX1 report
- Integra® Miltex® V916-160HEMOSTAT1 report
- Integra® Miltex® 19-790MALLET1 report
- Integra® Miltex® 30-1495FORCEPS, BIOPSY, GYNECOLOGICAL1 report
- Integra® Miltex® 40-224INSTRUMENT, MANUAL, SURGICAL, GENERAL USE1 report
- Integra® Miltex® 40-225AINSTRUMENT, MANUAL, SURGICAL, GENERAL USE1 report
- Integra® Miltex® 40-226-SSINSTRUMENT, MANUAL, SURGICAL, GENERAL USE1 report
- Integra® Miltex® 1-5001Loupe, binocular, low power1 report
- Integra® Miltex® 5-320SCISSORS, GENERAL, SURGICAL1 report
Recent Integra Miltex adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
OtherAug 17, 2026Nonstandard Device
Patient problems: Numbness
MAUDE report 50274694 ↗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 ↗InjuryJun 9, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS. INFLAMMATION WAS ALSO REPORTED.
Patient problems: Failure of Implant; Inflammation
MAUDE report 25449108 ↗MalfunctionApr 17, 2026Break
A FACILITY REPORTED THAT THE CA-JR TOFFLEMIRE TYPE RET (72-30) MATRIX BAND FELL OUT OF THE RETAINER WHILE IN THE PATIENT'S MOUTH. THERE WAS A SMALL DELAY IN TREATMENT OF APPROXIMATELY 30 MINUTES; HOWEVER, NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24911575 ↗InjuryMar 16, 2026Insufficient Device Problem Information
MalfunctionFeb 19, 2026Break
PATIENT FOUR OF THE REPORTED EVENTS- A FACILITY REPORTED THAT DURING AN IMPACTED WISDOM TEETH SURGICAL REMOVAL, THE CARBON SURGICAL BLADES 15 (4-115) FRACTURED INSIDE A PATIENT'S MOUTH, BREAKING DIRECTLY AT THE CUTTING SURFACE, AND IS CONCERNED FOR THE OPERATOR AND PRESENTS A SIGNIFICANT RISK OF PATIENT INJURY, AND HAD EXPERIENCED THIS ISSUE ON FIVE DIFFERENT OCCASIONS OVER THE LAST SIX MONTHS. ALL BROKEN PIECES WERE RETRIEVED FROM THE MOUTH USING A SURGICAL SNAP INSTRUMENT. THERE WAS NO REPORT OF PATIENT INJURIES OR DEATH, BUT A MINIMAL SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24392203 ↗MalfunctionFeb 19, 2026Break
MalfunctionFeb 18, 2026Break
MalfunctionFeb 18, 2026Break
MalfunctionFeb 12, 2026Break
InjuryFeb 3, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS AFTER INTENSE PAIN.
Patient problems: Failure of Implant; Implant Pain
MAUDE report 24245523 ↗MalfunctionFeb 2, 2026Break
InjuryJan 26, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS WITH INFECTION.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 24185966 ↗MalfunctionDec 1, 2025Nonstandard Device; Nonstandard Device
InjuryNov 13, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 23541065 ↗
Other Integra Lifesciences Production Corporation products
All Integra Lifesciences Production Corporation devices →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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