NA 232110Recalls & reported problems
Medos International Sàrl · ACL GRAFT KNIFE 10mm · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886705010998), received between Jan 25, 2021 and Nov 21, 2023 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Degraded” (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.
Reports received per month
Most reported problems
Device problems
- Degraded2
- Device Contaminated During Manufacture or Shipping2
- Delivered as Unsterile Product1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 21, 2023Degraded; Degraded
IT WAS REPORTED BY SALES REP THAT DURING UNKNOWN MULTIPLE PROCEDURES ON UNKNOWN DATES, ACL GRAFT KNIFE 10MM INSTRUMENTS WERE USED AND OBSERVED TO BE DULL. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18185358 ↗MalfunctionNov 21, 2023Degraded; Degraded
IT WAS REPORTED BY SALES REP THAT DURING UNKNOWN MULTIPLE PROCEDURES ON UNKNOWN DATES, ACL GRAFT KNIFE 10MM INSTRUMENTS WERE USED AND OBSERVED TO BE DULL. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18185268 ↗MalfunctionJun 23, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED BY THE SALES REP THAT UPON RECEIPT OF THE GRAFT INSTRUMENTS ACL GRAFT KNIFE 10MM DEVICE, IT WAS OBSERVED THAT A HAIR WAS FOUND INSIDE ITS STERILE POUCH. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17193373 ↗MalfunctionFeb 27, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED BY THE SALES REP THAT THERE WAS A HAIR INSIDE THE PACKAGE OF GRAFT INSTRUMENTS ACL GRAFT KNIFE 10MM DEVICE. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16448678 ↗MalfunctionJan 25, 2021Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED BY THE SALES REP THAT A HAIR WAS FOUND INSIDE THE STERILE PACKAGE OF THE GRAFT INSTRUMENTS ACL GRAFT KNIFE 10MM DEVICE. THERE WAS NO PROCEDURE OR PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11225571 ↗
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- DeRoyal D4511NS-500Deroyal Industries, Inc. · SCALPEL, ONE-PIECE1 report
- Bard-Parker ® Safety Scalped 372615Aspen Surgical Products, Inc. · SCALPEL, ONE-PIECE1 report
- Bard-Parker ® Safety Scalped 372621Aspen Surgical Products, Inc. · SCALPEL, ONE-PIECE1 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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