Arthrex® ABS-3005Recalls & reported problems
Arthrex, Inc. · QUICKSET KIT, 5CC · 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 00888867084384), received between Jun 7, 2024 and Jun 7, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Improper Chemical Reaction” (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
- Improper Chemical Reaction1
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.
MalfunctionJun 7, 2024Improper Chemical Reaction; Improper Chemical Reaction
ON 08/22/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN ABS-3005 QUICKSET KIT, 5CC HAD AN ISSUE. DURING A DISTAL FEMORAL OSTEOTOMY (DFO) PROCEDURE ON (B)(6) 2022, WHEN THE SURGEON WAS TRYING TO INJECT THE IMPLANT, IT NEVER HARDENED. SHE GAVE IT AN ADDITIONAL 6 MINUTES PAST THE RECOMMENDED TIME, AND IT STILL DID NOT HARDEN. THE SURGEON DECIDED TO REMOVE THE DEVICE WITH SUCTION, AS IT STARTED TO LEAK OUT OF THE BONE. THE SURGEON THEN PROCEEDED WITH THE DFO PROCEDURE, NO NEW IMPLANT WAS USED, AND THE CASE WAS COMPLETED SUCCESSFULLY WITH NO IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19491651 ↗
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- GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) T42200Medtronic Sofamor Danek, Inc. · FILLER, BONE VOID, CALCIUM COMPOUND2 recalls0 reports
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- GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) T44145Medtronic Sofamor Danek, Inc. · FILLER, BONE VOID, CALCIUM COMPOUND2 recalls0 reports
- GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) T43102Medtronic Sofamor Danek, Inc. · FILLER, BONE VOID, CALCIUM COMPOUND1 recall2 reports
- MAGNIFUSE® Bone Graft 7509014Medtronic Sofamor Danek, Inc. · FILLER, BONE VOID, CALCIUM COMPOUND1 recall2 reports
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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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