Arthrex® AR-2324PSLMRecalls & reported problems
Arthrex, Inc. · PEEK SWIVELOCK SP, 4.75x24.5MM · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867026926), received between Sep 20, 2023 and Jan 23, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (2 reports).
1 FDA recall record name this device's identifier.
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
Recalls naming this device
- Mar 24, 2017Class IITerminated
Some eyelets broke from SwiveLock Anchor on insertion.
Z-2044-2017 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Break2
- Material Deformation1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Failure of Implant1
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 23, 2026Break
ON 14-JAN-2026, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-2324PSLM SELF PUNCHING PEEK-SWIVELOCK ANCHOR BROKE DOWN. THIS WAS DISCOVERED DURING USE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24164199 ↗MalfunctionMay 6, 2024Break; Break
ON 09/07/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2324PSLM SUTURE ANCHOR, PEEK-SWIVELOCK® THE SECOND ANCHOR IS PLACED, IS WELL IMPACTED AND SCREWED IN CORRECTLY. WHEN THE HANDLES IS REMOVED AN EYELET AND ANCHOR ARE RELEASED. THIS WAS DISCOVERED DURING USE, WITH NO PATIENT AFFECT REPORTED. ADDITONAL INFORMATION REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19247867 ↗MalfunctionSep 20, 2023Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent
ON 8/28/2023, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT AN AR-2324PSLM PEEK-SWIVELOCK SP ANCHOR DEFORMED UPON INSERTION. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION RECEIVED ON 9/8/2023: THIS WAS DISCOVERED DURING A SHOULDER ARTHROSCOPY PROCEDURE. THE ANCHOR NEVER BROKE BUT DEFORMED WHEN IT TOUCHED BONE DURING INSERTION. THE CASE WAS COMPLETED USING AN AR-2324BCC BIOCOMPOSITE SWIVELOCK C. THE CASE WAS DELAYED AROUND FIVE MINUTES.
Patient problems: Failure of Implant; Insufficient Information
MAUDE report 17782526 ↗
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- HEALICOIL 72205137Smith & Nephew, Inc. · Fastener, fixation, biodegradable, soft tissue427 reports
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- Arthrex® AR-2324BCCArthrex, Inc. · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE254 reports
- HEALIX ADVANCE 222331Depuy Mitek, LLC · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE1 recall196 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 · each recall links to the FDA recall notice
- 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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