Arthrex® AR-3652SP-1Recalls & reported problems
Arthrex, Inc. · SP FbrTak RC TgrTpe WH/BLK & Sttpe WH/BL · Class 2 · Implant
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 00888867362918), received between Jul 24, 2025 and Jan 5, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Device Dislodged or Dislocated1
- Material Twisted/Bent1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 5, 2026Device Dislodged or Dislocated
ON 17TH DECEMBER 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-3652SP-1, FIBERTAK® RC SUTURE ANCHOR, (WHITE/BLACK), THE SURGEON INSERTED THE DEVICE. WHEN SURGEON REMOVED THE INSERTER GUIDE, THE FIBERTAK ANCHOR PULLED OUT OF THE BONE. THE TECHNIQUE THE SURGEON USED WAS THE CORRECT TECHNIQUE AND PRODUCT PULLED OUT AS A PRODUCT FAULT. THIS WAS DETECTED DURING A ROTATOR CUFF REPAIR - SPEEDBRIDGE USING FIBERTAK RC ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS A NEW FIBERTAK RC ANCHOR WAS USED.
Patient problems: Insufficient Information
MAUDE report 23959890 ↗MalfunctionJul 24, 2025Material Twisted/Bent; Material Twisted/Bent
ON 2ND JULY 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-3652SP-1, FIBERTAK® RC SUTURE ANCHOR, (WHITE/BLACK), WAS BENT AND THEREFORE DID NOT DEPLOY INTO THE BONE. THIS WAS DETECTED DURING USE IN A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS THEY OPTED TO USE AN AR-2324BCCT-1 SWIVELOCK ANCHOR INSTEAD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22586128 ↗
Other Fastener, fixation, nondegradable, soft tissue devices
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- OMNISPAN ORTHOCORD 228142Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE932 reports
- FOOTPRINT 72202901Smith & Nephew, Inc. · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE721 reports
- RIGIDLOOP 232447Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE633 reports
- Arthrex® AR-3636Arthrex, Inc. · Fastener, fixation, nondegradable, soft tissue624 reports
- OMNISPAN ORTHOCORD 228141Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE609 reports
- TRUESPAN ORTHOCORD 228162Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE460 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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