REELXRecalls & reported problems across all models
Stryker Corporation · 2 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 58
- Deaths reported
- 0
- Injuries reported
- 15
- Recalls
- 0
We found 2 models of REELX by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 58 adverse event reports in the FDA's MAUDE database, received between Jun 26, 2018 and Sep 26, 2025 — classified as 15 injuries, 43 malfunctions.
The most frequently reported specific device problem is “Break” (26 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported REELX problems
Device problems
- Break26
- Material Fragmentation13
- Device Dislodged or Dislocated10
- 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 Conditions46
- Insufficient Information15
- No Known Impact Or Consequence To Patient9
- Foreign Body In Patient5
- Failure of Implant2
- Device Embedded In Tissue or Plaque1
- No Code Available1
REELX models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- REELX 3910-600-062FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE47 reports
- REELX 3910-600-060FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE11 reports
Recent REELX adverse event reports
The 15 most recent reports across all models, 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 ↗
Other Stryker Corporation products
- RemB7 models · 3,073 reports
- Prime Series21 models · 1,548 reports · 2 recalls
- TARGET114 models · 1,077 reports
- ProCuity17 models · 368 reports · 13 recalls
- Spetzler-Malis20 models · 7 reports · 19 recalls
- SYNCHRO 28 models · 313 reports · 9 recalls
- Neptune E-SEP19 models · 412 reports · 7 recalls
- StrykeFlow4 models · 552 reports · 4 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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