NanoTackRecalls & reported problems across all models
Stryker Corporation · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 68
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls
- 0
We found 3 models of NanoTack by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 68 adverse event reports in the FDA's MAUDE database, received between Jun 11, 2018 and Jun 19, 2026 — classified as 7 injuries, 61 malfunctions.
The most frequently reported specific device problem is “Break” (45 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 NanoTack problems
Device problems
- Break45
- Expiration Date Error13
- Material Fragmentation7
- Material Deformation4
- Fracture2
- Activation, Positioning or Separation Problem1
- Appropriate Device Problem Term/Code Not Available1
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions54
- Insufficient Information18
- No Known Impact Or Consequence To Patient9
- Foreign Body In Patient5
- Device Embedded In Tissue or Plaque1
- No Consequences Or Impact To Patient1
NanoTack models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- NanoTack CAT01858FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE55 reports
- NanoTack CAT02969FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE8 reports
- NanoTack CAT01386FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE5 reports
Recent NanoTack adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJun 19, 2026Material Split, Cut or Torn
IT WAS REPORTED THAT FOR THE INVOLVED NANOTACK TT ANCHOR, WHILE TENSIONING THE ANCHOR USING THE NEW CURVED PIVOT KNOT PUSHER, THE TAPE RIPPED AT THE POINT WHERE IT INTERFACES WITH THE ANCHOR. AFTER THESE FAILURES, THE SURGEON MADE THE DECISION TO ABANDON THE LABRAL REPAIR AND INSTEAD DEBRIDE AND REMOVE THE PATIENT¿S LABRUM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25565872 ↗MalfunctionDec 30, 2025Expiration Date Error; Expiration Date Error
IT WAS REPORTED THAT AN EXPIRED NANOTACK FLEX ANCHOR WAS OPENED AND IMPLANTED INTO A PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23926646 ↗MalfunctionSep 3, 2025Break; Material Fragmentation; Break; Material Fragmentation
IT WAS REPORTED THAT THE NANOTACK GUIDE WAS PLACED ON THE ACETABULAR RIM. A NANOTACK DRILL WAS SUCCESSFULLY USED TO CREATE PILOT HOLE WITHOUT AND PROBLEMS. ANCHOR WAS INTRODUCED TO GUIDE AND MALLETED INTO BONE. TRIGGER ARMS ON ANCHOR WERE DEPLOYED, AND GUIDE WAS PULLED FROM JOINT. UPON THE REMOVAL OF THE NANOTACK GUIDE MULTIPLE PEEK FRAGMENTS OF THE NANOTACK FLEX ANCHOR WERE PROTRUDING FROM ACETABULAR RIM. MAJORITY OF ANCHOR REMAINED IN THE BONE BUT ABOUT 30% OF ANCHOR BODY FRAGMENTED INTO THE JOINT. THESE PIECES WERE REMOVED FROM THE JOINT SPACE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22956868 ↗MalfunctionSep 3, 2025Break; Material Fragmentation; Break; Material Fragmentation
IT WAS REPORTED THAT UPON DEPLOYMENT OF THE ANCHOR AND REMOVAL OF THE GUIDE, THE PEEK PORTION OF THE NANOTACK ANCHOR WERE PROTRUDING FROM THE JOINT. THE FRAGMENTED PIECES WERE PULLED FROM THE JOINT AND THE SUTURE PORTION PULLED OUT OF THE LEFTOVER ANCHOR AND OUT OF THE JOINT SPACE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22956858 ↗MalfunctionMay 20, 2025Fracture; Fracture
IT WAS REPORTED THAT AFTER SURGEON UNRAVELED THE SUTURE ON THE INSERTER, IT WAS NOTICED THAT THE FLEXIBLE INSERTER FROM THE ANCHOR HAD BROKEN OFF DISTALLY. THE SURGEON PULLED BACK ON THE INSERTER AND DRILL GUIDE TO PULL THE BROKEN IMPLANT OUT BUT A PIECE OF THE ANCHOR INSERTER BROKE OFF. WITH THE HELP OF X-RAY, THE SURGEON WAS ABLE TO RETRIEVE THE FLOATING PIECE IN THE CAPSULE. THE SURGEON WAS NOT ABLE TO RETRIEVE THE PIECE OF METAL FROM THE INSERTER THAT WAS IMPLANTED INTO THE BONE, SO THE SURGEON WAS ABLE TO BUR DOWN FLAT WITH THE BONE.
Patient problems: Foreign Body In Patient
MAUDE report 22057651 ↗InjuryApr 4, 2025Break; Fracture; Break; Fracture
IT WAS REPORTED THAT THE NANOTACK FLEX ANCHORS HAVE BEEN UNCOILING WHILE REMOVING THE INSERTION HANDLE AND REPORTEDLY CAUSING WEAK POINTS TO OCCUR. IT WAS REPORTED THAT THE INSERTER BROKE UPON ANCHOR DEPLOYMENT AND INSERTER WAS NOT ABLE TO BE REMOVED FROM PATIENT ANATOMY. REPORTEDLY SURGEON WAS NOT WORRIED ABOUT FURTHER HARM.
Patient problems: Foreign Body In Patient
MAUDE report 21775972 ↗InjuryDec 17, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED BY THE CUSTOMER THAT "THE TIP OF THE NANO TACK ANCHOR MECHANISM BROKE WHEN BEING MALLETED INTO THE BONE. THE SURGEON NOTED THAT SOME OF THE MECHANISM WOULD BE LEFT IMBEDDED IN THE PATIENTS' BONE AS THEY WERE NOT ABLE TO RETRIEVE IT AFTER THE ANCHOR WENT IN".
Patient problems: Foreign Body In Patient
MAUDE report 20951709 ↗InjuryOct 8, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE ANCHOR POTENTIALLY BROKE DURING THE PROCEDURE AND THE PIECES POTENTIALLY REMAINED IN THE PATIENT.
Patient problems: Insufficient Information
MAUDE report 20402353 ↗MalfunctionFeb 28, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE ANCHOR BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18803789 ↗MalfunctionJan 31, 2024Material Fragmentation; Separation Failure; Material Fragmentation; Separation Failure
PER INVESTIGATION RESULTS, THE ANCHOR WAS BROKEN. BASED ON THIS, THE ANCHOR BROKE DURING THE PROCEDURE. THE BROKEN PIECE WAS NOT LEFT IN PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18619853 ↗MalfunctionNov 10, 2023Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE ANCHOR BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18112730 ↗MalfunctionMay 22, 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 16981451 ↗MalfunctionMay 22, 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 16981450 ↗MalfunctionMay 22, 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 16981449 ↗MalfunctionMay 22, 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 16981448 ↗
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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