ACTIS 2010-04-600Recalls & reported problems
Depuy (Ireland) · ACTIS FLX REAMER CASE BASE · Class 1
All models of ACTIS (97)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295393924), received between Jul 23, 2024 and Jul 28, 2025 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Peeled/Delaminated” (5 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Peeled/Delaminated5
- No Apparent Adverse Event2
- Scratched Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions8
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 28, 2025No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED THAT THE PINNACLE UTILITY CASE AND ACTIS CORE CASE BASE WERE PEELING, ACTIS FLX REAMER CASE BASE REPORTED FOR AN UNKNOWN REASON. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22628826 ↗MalfunctionJul 18, 2025Scratched Material; Scratched Material
IT WAS REPORTED THAT THE DEVICE WAS PEELING AND SCRATCHED. IT DIDN'T HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22543990 ↗MalfunctionJul 1, 2025Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE DEVICE WAS PEELING, IT DIDN'T HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22378363 ↗MalfunctionFeb 26, 2025No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED THAT THE TRAYS ARE FLAKING DEBRIS; THE COATING IS PEELING. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21471123 ↗MalfunctionFeb 18, 2025Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE TRAYS WERE FLAKING DEBRIS. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21398804 ↗MalfunctionFeb 18, 2025Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE TRAYS WERE FLAKING DEBRIS. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21395588 ↗MalfunctionFeb 18, 2025Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE TRAYS WERE FLAKING DEBRIS. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21395459 ↗MalfunctionJul 23, 2024Peeled/Delaminated; Peeled/Delaminated
ADDITIONAL INFORMATION RECEIVED STATES THAT DURING THE VISUAL EXAMINATION ON (02/11/2025), IT WAS OBSERVED THAT THE DEVICES (201004600/PV0158603; 201004600/PV0204733; 201004600/PV0195574) HAD PEELING COATINGS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19806675 ↗
Other TRAY, SURGICAL, INSTRUMENT devices
- PINNACLE 2220-00-100Depuy (Ireland) · TRAY, SURGICAL, INSTRUMENT74 reports
- ACTIS 2010-04-200Depuy (Ireland) · TRAY, SURGICAL, INSTRUMENT66 reports
- ATTUNE 2545-01-703Depuy (Ireland) · TRAY, SURGICAL, INSTRUMENT62 reports
- ATTUNE 2545-01-704Depuy (Ireland) · TRAY, SURGICAL, INSTRUMENT57 reports
- Calibrate CLCCXSIMPAAlphatec Spine, Inc. · TRAY, SURGICAL, INSTRUMENT1 recall0 reports
- n.a. 39501BECKarl Storz GmbH & Co. KG · TRAY, SURGICAL, INSTRUMENT1 recall0 reports
- n.a. 39501XKKarl Storz GmbH & Co. KG · TRAY, SURGICAL, INSTRUMENT1 recall0 reports
- n.a. 39501A2Karl Storz GmbH & Co. KG · TRAY, SURGICAL, INSTRUMENT1 recall0 reports
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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