Arthrex® AR-9107-02-25RRecalls & reported problems
Arthrex, Inc. · AUGMENTED VAULTLOCK, MEDIUM 25R · Class 2 · Implant
Data updated Oct 18, 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 00888867350717), received between Jan 12, 2026 and Jan 12, 2026 — classified as 1 malfunction.
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. 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
- Break1
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.
MalfunctionJan 12, 2026Break
ON (B)(60 2025, A DISTRIBUTOR REPORTED VIA EMAIL THAT AN AR-9107-02-25R UNIVERS VAULTLOCK AUGMENTED GLENOID, MEDIUM 25R HAD ITS CENTRAL PEG BREAK OFF THE IMPLANT PRIOR TO IMPLANTATION (SEE ATTACHED PHOTO). THE ISSUE WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 24-DEC-2025: DURING A TOTAL SHOULDER ARTHROPLASTY UTILIZING AN AUGMENTED VAULTLOCK GLENOID AND ECLIPSE SYSTEM, THE CENTRAL PEG OF AN AR-9107-02-25R UNIVERS VAULTLOCK AUGMENTED GLENOID, MEDIUM 25R BROKE WHILE APPLYING GRAFT WITH THE GRAFT COMPRESSION TOOL PRIOR TO IMPLANTATION. ALL COMPONENTS WERE RETRIEVED BEFORE USE. A REPLACEMENT AR-9107-02-15R UNIVERS VAULTLOCK AUGMENTED GLENOID, MEDIUM 15R WAS IMPLANTED INSTEAD. THE EVENT RESULTED IN AN APPROXIMATE 5¿10 MINUTE DELAY, WITH NO ADDITIONAL ANESTHESIA ADMINISTERED. BONE QUALITY WAS ASSESSED AS NORMAL, AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24036219 ↗
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- DJO SURGICAL 509-00-436Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented124 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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