ICONIXRecalls & reported problems across all models
Stryker Corporation · 18 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 117
- Deaths reported
- 0
- Injuries reported
- 57
- Recalls
- 0
We found 18 models of ICONIX by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 117 adverse event reports in the FDA's MAUDE database, received between Jul 30, 2018 and Aug 27, 2026 — classified as 57 injuries, 60 malfunctions.
The most frequently reported specific device problem is “Break” (48 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 ICONIX problems
Device problems
- Break48
- Adverse Event Without Identified Device or Use Problem12
- Expiration Date Error11
- Fracture11
- Material Fragmentation8
- Patient Device Interaction Problem7
- Appropriate Device Problem Term/Code Not Available4
- Material Separation4
Patient problems
- No Clinical Signs, Symptoms or Conditions73
- Foreign Body In Patient32
- Insufficient Information17
- No Known Impact Or Consequence To Patient11
- Pain6
- Unspecified Infection6
- Device Embedded In Tissue or Plaque4
- No Code Available4
ICONIX models
18 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ICONIX 3910-500-512FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE30 reports
- ICONIX 3910500322FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE14 reports
- ICONIX 3910-500-522FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE13 reports
- ICONIX 3910500312FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE10 reports
- ICONIX 3910500222Fastener, fixation, nondegradable, soft tissue7 reports
- ICONIX 3910500922Fastener, fixation, nondegradable, soft tissue7 reports
- ICONIX 3910500931Fastener, fixation, nondegradable, soft tissue7 reports
- ICONIX 3910500920Fastener, fixation, nondegradable, soft tissue6 reports
- ICONIX 3910-500-573BIT, DRILL5 reports
- ICONIX 3910-500-532FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE3 reports
- ICONIX 3910-500-568BIT, DRILL3 reports
- ICONIX 3910500212Fastener, fixation, nondegradable, soft tissue3 reports
- ICONIX 3910-500-525FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE2 reports
- ICONIX 3910500422Fastener, fixation, nondegradable, soft tissue2 reports
- ICONIX 3910500412Fastener, fixation, nondegradable, soft tissue2 reports
- ICONIX 3910-500-569BIT, DRILL1 report
- ICONIX 3910-500-571BIT, DRILL1 report
- Iconix 3910500580Accessories, arthroscopic1 report
Recent ICONIX adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryAug 27, 2026Fracture
It was reported that the broken tip portion of the ICONIX remained in the patient's glenoid cavity.
Patient problems: Foreign Body In Patient
MAUDE report 50488472 ↗InjuryAug 26, 2026Fracture
It was reported that a 2.3mm Iconix needle was used in the surgery. After the preparation of pilot hole by using the dedicated disposable drill in the same package, the anchor was malleted through the drill guide. However, after pulling out the handle of the anchor, it was found that the distal part of the shaft was bent and one of the tips was also broken and left in the patient. The surgeon spent about 10 mins to find the broken tip in the patient, and redeploy another new anchor. There¿s no other impact to the patient.
Patient problems: Foreign Body In Patient
MAUDE report 50462580 ↗InjuryJun 12, 2026Material Fragmentation
It was reported that after drill hole was prepared using a 2.3mm drill and the anchor was impacted into the bone, the inserter shaft was removed and found the tip was missing. The missing tip was about 1mm and could not be found on table. It was believed that the tip was left in the anchor, which was inside the patient's glenoid intrabony. The doctor thought that the metal piece was fixed inside bone and decided to continue the surgery without removing it.
Patient problems: Foreign Body In Patient
MAUDE report 25487285 ↗MalfunctionJun 11, 2026Delivered as Unsterile Product
It was reported that when opening the package, it was noticed that one side of the packaging was not sealed, meaning the item was not sterile.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25476784 ↗MalfunctionJun 11, 2026Delivered as Unsterile Product
It was reported that when opening the package, it was noticed that one side of the packaging was not sealed, meaning the item was not sterile.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25476783 ↗MalfunctionApr 20, 2026Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT A FOREIGN MATERIAL (SUSPECTED TO BE HAIR) WAS FOUND INSIDE A STERILIZED POUCH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24932502 ↗InjuryJan 16, 2026Fracture
IT WAS REPORTED THAT AFTER INSERTING THE ANCHOR AND REMOVING THE INSERTER, ONE PRONG OF THE DISTAL FORK WAS FOUND TO BE FRACTURED. IT WAS LATER CONFIRMED THAT THE FRACTURED PRONG REMAINED INSIDE THE BONE ALONG WITH THE ANCHOR.
Patient problems: Foreign Body In Patient
MAUDE report 24099946 ↗MalfunctionJan 16, 2026Material Fragmentation; Device Dislodged or Dislocated
IT WAS REPORTED THAT DURING IMPLANT PLACEMENT, THE ANCHOR GOT LOOSE AND IT WAS NOT EMBEDDED IN THE BONE, ANOTHER IMPLANT WAS USED IN THE SAME CANAL. IMPLANT WAS RETRIEVED FROM PATIENT BODY. THERE WERE NO DEVICE FRAGMENTS LEFT IN PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24099195 ↗MalfunctionOct 28, 2025Expiration Date Error; Expiration Date Error
IT WAS REPORTED THAT THE DEVICE HAD A DATE OF EXPIRATION OF (B)(6) 2025 AND IT WAS IMPLANTED ON (B)(6) 2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23408570 ↗MalfunctionSep 24, 2025Fracture; Fracture
IT WAS REPORTED THAT THE TIP OF THE INSERTER BROKE OFF, LEAVING FRAGMENTS IN THE PATIENT'S BONE.
Patient problems: Foreign Body In Patient
MAUDE report 23139111 ↗MalfunctionJun 10, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT IN A HIP SCOPE, IT WAS NOTICED TWO ANCHORS DEPLOYED THAT WERE DAMAGED FROM THE GUIDE IN A VERY UNUSUAL MANNER. THE DOCTOR MENTIONED THE TIP OF THE GUIDE FELT SHARP AND LOOKED BROKEN. AFTER EXAMINATION, A PART OF THE TIP OF THE GUIDE HAD BROKEN LEAVING A SHARP EDGE TO DAMAGE SUTURE. ALL BROKEN PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22178171 ↗MalfunctionJun 4, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE TIP OF AN ICONIX DRILL BROKE OFF DURING DRILLING. THE BROKEN FRAGMENT REMAINED TEMPORARILY IN THE JOINT, BUT WAS IMMEDIATELY REMOVED AND LEFT NO RESIDUE IN THE PATIENT'S BODY. THE DEVICE WAS USED FOR THE FIRST TIME AFTER PURCHASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22146508 ↗InjuryApr 29, 2025Fracture; Fracture
IT WAS REPORTED THAT THE TIP OF THE INSTRUMENT HOLDING THE ANCHOR BROKE OFF DURING IMPLANT INSERTION. THE TIP OF THE ICONIX REMAINED IN THE PATIENT BONE.
Patient problems: Foreign Body In Patient; Insufficient Information
MAUDE report 21931158 ↗MalfunctionMar 26, 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 21702292 ↗MalfunctionMar 19, 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 21647796 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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