REELX 3910-600-062Recalls & reported problems
Stryker Corporation · 4.5MM STRYKER REELX STT ANCHOR · Class 2 · Implant
All models of REELX (2)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Stryker ReelX soft-tissue anchor is a small suture anchor used to fix tissue to bone. The 47 reports mostly describe the anchor breaking during surgery, sometimes leaving pieces in the joint, and coming loose or out of the bone; 10 reports involved injuries and no deaths were reported. There are no recalls naming this device, and no reports were filed in the past 12 months compared with 6 the year before.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 47
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 07613252592808), received between Jul 24, 2018 and Sep 26, 2025 — classified as 10 injuries, 37 malfunctions.
The most frequently reported specific device problem is “Break” (22 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break22
- Material Fragmentation13
- Device Dislodged or Dislocated4
- Expiration Date Error3
- Fracture2
- Adverse Event Without Identified Device or Use Problem1
- Appropriate Device Problem Term/Code Not Available1
- Insufficient Device Problem Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions36
- Insufficient Information10
- No Known Impact Or Consequence To Patient8
- Foreign Body In Patient4
- Failure of Implant2
- Device Embedded In Tissue or Plaque1
- No Code Available1
Recent adverse event reports
The 25 most recent of 47 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 26, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE REELX BROKE OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23157983 ↗MalfunctionSep 26, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE REELX BROKE OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23156004 ↗MalfunctionSep 26, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE REELX BROKE OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23155793 ↗MalfunctionFeb 12, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE ANCHOR BROKE DURING THE PROCEDURE. THE ANCHOR WAS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21368799 ↗MalfunctionFeb 12, 2025Expiration Date Error; Expiration Date Error
IT WAS REPORTED THAT AN EXPIRED PRODUCT WAS USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21368635 ↗MalfunctionFeb 5, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE ANCHOR BROKE DURING THE PROCEDURE. IT WAS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21315907 ↗InjuryMay 3, 2024Premature Separation; Premature Separation
IT WAS REPORTED THAT THE REELX WAS LOADED WITH FOUR #2 SUTURE ENDS AND INSERTED DIRECTLY INTO THE SOFT BONE AND FIXED WITH AT LEAST ONE TURN. THE OPERATION WAS COMPLETED. THE SUBSEQUENT X-RAY EXAMINATION SHOWED THAT THE ANCHOR HAD BECOME DETACHED FROM THE BONE. A REVISION SURGERY WAS PERFORMED. THE ANCHOR WAS REMOVED FROM THE JOINT USING GRASPING FORCEPS; ONE HALF OF THE ANCHOR HAD FLAKED OFF. THE REFIXATION WAS RENEWED WITH A DIFFERENT ANCHOR SYSTEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19238578 ↗InjuryMay 3, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE REELX WAS LOADED WITH FOUR #2 SUTURE ENDS AND DRIVEN DIRECTLY INTO THE SOFT BONE. A ROTATION OF THE BLACK KNOB WAS PERFORMED, THE ROTATION COULD BE PERFORMED WITH LITTLE RESISTANCE, A SUDDEN CANCELLATION OF THE RESISTANCE WAS NOT FELT. THE INSERTER WAS RELEASED. DURING ARTHROSCOPIC EXAMINATION OF THE ANCHOR, THE SURGEON NOTICED THAT IT WAS COMING OUT OF THE BONE AGAIN. THE ANCHOR WAS PULLED OUT AGAIN WITH GRASPING FORCEPS, ONE HALF OF THE ANCHOR HAD FLAKED OFF. THE CHIPPED PART COULD NOT BE FOUND. IN ORDER TO REMOVE THE ANCHOR FROM THE JOINT, THE SUTURES WERE CUT AND THE ANCHOR BODY REMOVED. THE OPERATION WAS CONTINUED WITH A DIFFERENT ANCHOR SYSTEM AND THE REFIXATION WAS RENEWED.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 19238577 ↗MalfunctionMay 3, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT AFTER IMPLANTATION OF THE ANCHOR, SOME FRACTURE PIECE WERE NOTICED IN AREA OF PEEK END. THE PIECE WAS REMOVED. DURING ATTEMPTS TO TENSION THE THREAD, AFTER ONE TURN IT WAS NOT POSSIBLE TO CONTINUE, THERE WAS NO POSSIBILITY TO TIGHTEN. IT WAS NECESSARY TO CUT THE THREADS. THE ANCHOR WAS LEFT, AS IT WAS PROPERLY SET BUT IT WAS NOT FUNCTIONAL. THERE WAS A 30 MINUTE DELAY. THE IMPLANT REMAINED IN THE SHOULDER BONE, WHICH MAY REQUIRE ADDITIONAL SURGERY OR TREATMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19238569 ↗MalfunctionApr 12, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE TUNNEL WAS MADE WITH THE DRILL BIT AND ITS GUIDE, THEN THE ANCHOR WAS ENTERED INTO THE PREVIOUSLY MADE HOLE, IT PROCEEDED TO IMPACT UP TO THE GUIDE LINE AND WHEN IT WAS IN THE MIDDLE, IT FRACTURED IN THE BODY. THE PIECES WERE POTENTIALLY NOT ABLE TO BE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19098010 ↗MalfunctionFeb 29, 2024Expiration Date Error; Expiration Date Error
IT WAS REPORTED THAT AN EXPIRED PRODUCT WAS USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18810890 ↗MalfunctionFeb 27, 2024Expiration Date Error; Expiration Date Error
IT WAS REPORTED THAT AN EXPIRED PRODUCT WAS USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18793835 ↗InjuryDec 21, 2023Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE ANCHOR POTENTIALLY BROKE DURING THE PROCEDURE AND THE PIECES WERE POTENTIALLY UNABLE TO BE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18380565 ↗MalfunctionDec 13, 2023Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT WHILE DOING SHOULDER SURGERY THE ITEM GOT BROKEN. THE BROKEN PIECES WERE POTENTIALLY UNABLE TO BE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18323492 ↗MalfunctionNov 8, 2023Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT ANCHOR BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18097170 ↗MalfunctionSep 29, 2023Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE ANCHOR BROKE DURING PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17844959 ↗MalfunctionJun 19, 2023Break; Break
IT WAS REPORTED THAT THE PEEK OF THE IMPLANT FRACTURED AND REMAINED IN THE JOINT OF THE PATIENT. THE PROCEDURE COULD NOT BE FINISHED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17159871 ↗MalfunctionApr 21, 2023Break; Break
IT WAS REPORTED THAT THE ANCHOR BROKE DURING PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16792099 ↗MalfunctionJan 5, 2023Break; Break
IT WAS REPORTED THAT THE ANCHOR POTENTIALLY BROKE DURING PROCEDURE AND PIECES WERE POTENTIALLY UNABLE TO BE RETRIEVED.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 16106453 ↗MalfunctionDec 21, 2022Break
IT WAS REPORTED THAT THE ANCHOR BROKE DURING PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16024571 ↗MalfunctionMay 19, 2022Break
IT WAS REPORTED THAT THE ANCHOR BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14434632 ↗MalfunctionMay 19, 2022Break
IT WAS REPORTED THAT THE ANCHOR BROKE DURING THE PROCEDURE. ALL PIECES WERE ABLE TO BE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14434365 ↗MalfunctionMar 28, 2022Material Fragmentation; Break; Material Fragmentation
IT WAS REPORTED THAT THE ANCHOR BROKE. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13934563 ↗MalfunctionSep 15, 2021Break
IT WAS REPORTED THAT THE ANCHOR BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12474881 ↗MalfunctionSep 15, 2021Break
IT WAS REPORTED THAT THE ANCHOR BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12474771 ↗
Other FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE devices
- TRUESPAN ORTHOCORD 228151Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE1,686 reports
- TRUESPAN ORTHOCORD 228152Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE1,398 reports
- 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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