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Arthrex® AR-8330RHRecalls & reported problems

Arthrex, Inc. · SHAVER HP, ASPII, HAND CONTROL, BACKHAND · Class 1

Data updated Oct 16, 2026 from official FDA records · Editorial policy

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 00888867043244), received between Nov 29, 2023 and Jun 4, 2024 — classified as 2 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

Nov 2023: 1 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 1 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Positioning Failure2
  • Use of Device Problem1

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.

  • MalfunctionJun 4, 2024Positioning Failure; Positioning Failure

    ON 05/07/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8330RH SHAVER HAS SOME BIO BURDEN AT THE BOTTOM OF IT, CAUSING THE SHAVER TO NOT LOCK. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19460899 ↗
  • MalfunctionNov 29, 2023Positioning Failure; Use of Device Problem; Positioning Failure; Use of Device Problem

    ON 11/02/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8330RH SHAVER WONT HOLD BLADES. THIS WAS DISCOVERED DURING USE IN A CASE WITH NO PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18226936 ↗

Other INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT devices

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Sources and updates

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