Arthrex® AR-8981BCTJ-CPRecalls & reported problems
Arthrex, Inc. · Implant Sys, DX KL SL, BC,4.75 mm, CC FT · 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
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867320734), received between Mar 11, 2024 and Jun 2, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Device Dislodged or Dislocated2
- Failure to Fire1
- Positioning Failure1
Patient problems
- Insufficient Information2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 2, 2025Positioning Failure; Device Dislodged or Dislocated; Positioning Failure; Device Dislodged or Dislocated
ADDITIONAL INFORMATION WAS RECEIVED ON 6/2/2025: DURING THE PROCEDURE, THE IMPLANT REMAINED SECURELY INSIDE THE PATIENT'S BONE, AND NO FRAGMENTS WERE LEFT INSIDE THE PATIENT. THE CASE EXPERIENCED A FIFTEEN-MINUTE DELAY DUE TO THE MALFUNCTION; HOWEVER, THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO ADDITIONAL ANESTHESIA WAS REQUIRED BEYOND THE ORIGINAL PLAN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22123936 ↗MalfunctionJul 17, 2024Failure to Fire; Failure to Fire
ON 06/27/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS- (B)(4) THAT AN AR-8981BCTJ-CP IMPLANT SYSTEM AND AN AR-8982BCT DX KNOTLESS SWIVELOCK KNOTLESS MECHANISM WAS NOT FIRING CORRECTLY IN THESE PROXIMAL ANCHORS. THIS OCCURRED DURING A CASE BOTH ANCHORS WERE PULLED OUT AND THE CASE WAS COMPLETED USING OTHER ANCHORS.
Patient problems: Insufficient Information
MAUDE report 19764518 ↗MalfunctionMar 11, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
ON 02/20/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8981BCTJ-CP IMPLANT SYS, DX KL SL, BC,4.75 MM, CC FT KNOTLESS MECHANISM PULLED OUT OF ANCHOR ALONG WITH EYELET. ANCHOR WAS DEFECTIVE.
Patient problems: Insufficient Information
MAUDE report 18874260 ↗
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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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