Arthrex® AR-9511-2Recalls & reported problems
Arthrex, Inc. · Univers Revers Apex Impactor/Extractor · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867301870), received between Jan 25, 2024 and Jan 7, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (3 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
- Break3
- Device Damaged by Another Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 7, 2025Break; Break
ADDITIONAL INFORMATION WAS RECEIVED ON 12/31/2024: THIS WAS DISCOVERED DURING A REVERSE TOTAL SHOULDER PROCEDURE ON (B)(6) 2024. THERE WAS NO CASE DELAY AND NO ADVERSE EFFECTS ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21093497 ↗MalfunctionApr 22, 2024Device Damaged by Another Device; Device Damaged by Another Device
IT WAS REPORTED THAT THE THREADS ON THE AR-9511-2 ARE DAMAGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19155005 ↗MalfunctionJan 30, 2024Break; Break
ON 01/08/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9511-2 IMPACTOR EXTRACTOR WAS WORN AND BROKE. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18607897 ↗MalfunctionJan 25, 2024Break; Break
ON 01/02/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9511-2 EXTRACTOR FASTENER BROKE DURING EXTRACTION. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18581277 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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