OpteCure 650-00-01Recalls & reported problems
Exactech, Inc. · Class 2 · Implant
Data updated Oct 16, 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 10885862094780), received between Mar 20, 2024 and Mar 20, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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
- Contamination /Decontamination Problem1
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.
MalfunctionMar 20, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED, THE DOCTOR FOUND AN UNIDENTIFIED WHITE SOLID INSIDE THE PRODUCT WHEN HE WAS ABOUT TO USE IT. IMAGES RECEIVED. THE DEVICE WILL BE RETURN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18944457 ↗
Other Bone Grafting Material, Human Source devices
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- GRAFTON® DBM T43103INTMedtronic Sofamor Danek, Inc. · BONE GRAFTING MATERIAL, HUMAN SOURCE1 recall0 reports
- GRAFTON® DBM T43101INTMedtronic Sofamor Danek, Inc. · BONE GRAFTING MATERIAL, HUMAN SOURCE1 recall0 reports
- GRAFTON® DBM T43105INTMedtronic Sofamor Danek, Inc. · BONE GRAFTING MATERIAL, HUMAN SOURCE1 recall0 reports
- DynaBlast 10.210.1050Keystone Dental, Inc. · BONE GRAFTING MATERIAL, HUMAN SOURCE3 reports
- GRAFTON® DBM T42308INTMedtronic Sofamor Danek, Inc. · BONE GRAFTING MATERIAL, HUMAN SOURCE1 report
- GRAFTON® DBM T43110INTMedtronic Sofamor Danek, Inc. · BONE GRAFTING MATERIAL, HUMAN SOURCE1 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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