Arthrex® AR-1312Recalls & reported problems
Arthrex, Inc. · RASP, GLENOID · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867007710), received between Mar 14, 2025 and Apr 17, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Positioning Failure” (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
- Positioning Failure2
- Defective Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 17, 2025Defective Device; Defective Device
ON 04/01/2025, A SALES REPRESENTATIVE VIA (B)(6) REPORTED THAT AN AR-1312 GLENOID RASP AND AN AR-1309 SLAP RASP WERE NOT FITTING DOWN 7MM CANNULAS. THIS WAS DISCOVERED DURING A SHOULDER CASE BUT THE PATIENT WAS NOT AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21860292 ↗MalfunctionMar 14, 2025Positioning Failure; Positioning Failure
ON 02/26/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (QTY. 2) OF AN AR-1312 RASP, GLENOID WOULD NOT GO DOWN ON THE 7MM CANNULA. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21606421 ↗MalfunctionMar 14, 2025Positioning Failure; Positioning Failure
ON 02/26/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (QTY. 2) OF AN AR-1312 RASP, GLENOID WOULD NOT GO DOWN ON THE 7MM CANNULA. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21606352 ↗
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- FirstPass 72290129Smith & Nephew, Inc. · Accessories, arthroscopic82 reports
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- MITEK 242025Medos International Sàrl · ACCESSORIES,ARTHROSCOPIC61 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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