Arthrex® AR-2370Recalls & reported problems
Arthrex, Inc. · Low-Profile AC Implant Device · Class 2 · Implant
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867224247), received between Jun 28, 2021 and Mar 23, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 23, 2026Material Split, Cut or Torn
IT WAS REPORTED THAT DURING THE ARTHROSCOPY, THE SUTURE SNAPPED WHILE THE SYSTEM WAS BEING TENSIONED. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24662747 ↗MalfunctionJun 28, 2021Break
IT WAS REPORTED THAT THE TIGHTENING SUTURE OF THE DEVICE BROKE ON THE COLLARBONE SIDE DURING AN ACROMIOCLAVICULAR REPAIR SURGERY. THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12076084 ↗
Other WASHER, BOLT NUT devices
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- Arthrex® AR-2372BLOArthrex, Inc. · WASHER, BOLT NUT91 reports
- Arthrex® AR-8925SSArthrex, Inc. · WASHER, BOLT NUT79 reports
- Arthrex® AR-8925TArthrex, Inc. · WASHER, BOLT NUT71 reports
- Arthrex® AR-8926TArthrex, Inc. · WASHER, BOLT NUT61 reports
- RipCord STA001KTrimed, INC. · WASHER, BOLT NUT1 recall2 reports
- Arthrex® AR-7000-18TArthrex, Inc. · WASHER, BOLT NUT1 recall0 reports
- Arthrex® AR-8926SSArthrex, Inc. · WASHER, BOLT NUT35 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.