CinchLock FlexRecalls & reported problems across all models
Stryker Corporation · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one CinchLock Flex model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 59
- Deaths reported
- 0
- Injuries reported
- 17
- Recalls
- 1
We found 2 models of CinchLock Flex by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 59 adverse event reports in the FDA's MAUDE database, received between Aug 28, 2018 and Mar 10, 2026 — classified as 17 injuries, 42 malfunctions.
The most frequently reported specific device problem is “Fracture” (26 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
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
CinchLock Flex recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jan 29, 2025Open, Classified
Increase in complaints concerning "pullwire" breakage that may result in the broken pullwire remaining in the anchor implant body after deployment.
Z-1328-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported CinchLock Flex problems
Device problems
- Fracture26
- Break24
- Detachment of Device or Device Component4
- Difficult to Remove4
- Material Fragmentation4
- Activation, Positioning or Separation Problem3
- Entrapment of Device3
- Physical Resistance/Sticking2
Patient problems
- No Clinical Signs, Symptoms or Conditions42
- Foreign Body In Patient10
- Insufficient Information10
- No Known Impact Or Consequence To Patient9
- Device Embedded In Tissue or Plaque2
- No Information1
CinchLock Flex models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- CinchLock Flex CAT02643FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE1 recall58 reports
- CinchLock Flex CAT02974BIT, DRILL1 report
Recent CinchLock Flex adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMar 10, 2026Material Fragmentation
IT WAS REPORTED THAT THE ANCHOR DID NOT RELEASE PROPERLY AND LEAD TO THE SUTURE BEING CUT AND HALF THE ANCHOR REMAINED ON THE DEPLOYMENT HANDLE. THIS LEAD TO NO SUTURE, HALF THE ANCHOR BEING LEFT IN THE BONE.
Patient problems: Foreign Body In Patient
MAUDE report 24560115 ↗MalfunctionAug 26, 2025Fracture; Fracture
IT WAS REPORTED THAT A PULL WIRE BREAKAGE OCCURRED IN A CASE AND IT WAS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22898100 ↗MalfunctionApr 15, 2025Fracture; Fracture
IT WAS REPORTED THAT THE CINCHLOCK FLEX IMPLANT FAILED TO RELEASE THE NITINOL WIRE FROM THE IMPLANT UPON DEPLOYMENT. THERE WAS A SMALL AMOUNT OF THE WIRE LEFT IN THE IMPLANT WHICH MAY OR MAY NOT BECOME AN ISSUE GOING FORWARD. FOR THIS DEVICE, THE PULL WIRE WAS NOT LEFT IN PATIENT.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 21844597 ↗InjuryFeb 27, 2025Fracture; Fracture
IT WAS REPORTED THAT WHEN THE ANCHOR WAS RELEASED, THE WIRE BROKE AND REMAINED IN THE ANCHOR. THE ANCHOR OR WIRE COULD BE REMOVED FROM THE PATIENT, ALTHOUGH IT BROKE INTO SEVERAL PIECES. THE SURGEON THINKS THAT THE WIRE BROKE WHEN HE RETURNED THE RELEASE LEVER TO ITS ORIGINAL POSITION. A RESIDUAL PIECE WAS LEFT IN THE BONE. IT WAS IMPOSSIBLE TO REMOVE FOREIGN BODY.
Patient problems: Insufficient Information
MAUDE report 21485090 ↗MalfunctionFeb 27, 2025Fracture; Fracture
IT WAS REPORTED THAT THE PULL WIRE REMAINED IN THE ANCHOR. THE PULL WIRE WAS ABLE TO BE REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21484619 ↗MalfunctionFeb 21, 2025Fracture; Fracture
IT WAS REPORTED THAT THE PULL WIRE REMAINED IN THE ANCHOR. THE PULL WIRE WAS ABLE TO BE REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21435234 ↗MalfunctionDec 17, 2024Fracture; Fracture
IT WAS REPORTED THAT THE PULL WIRE REMAINED IN THE ANCHOR. THE PULL WIRE WAS ABLE TO BE CUT OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20951695 ↗MalfunctionDec 12, 2024Fracture; Fracture
IT WAS REPORTED THAT THE PULL WIRE REMAINED IN THE ANCHOR. THE PULL WIRE WAS ABLE TO BE CUT OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20919572 ↗MalfunctionDec 11, 2024Fracture; Fracture
IT WAS REPORTED THAT THE PULL WIRE REMAINED IN THE ANCHOR. THE PULL WIRE WAS ABLE TO BE REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20908412 ↗MalfunctionNov 27, 2024Fracture; Fracture
IT WAS REPORTED THAT THE CINCHLOCK FLEX IMPLANT FAILED TO RELEASE THE NITINOL WIRE FROM THE IMPLANT UPON DEPLOYMENT. THERE WAS A SMALL AMOUNT OF THE WIRE LEFT IN THE IMPLANT WHICH MAY OR MAY NOT BECOME AN ISSUE GOING FORWARD.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 20799885 ↗MalfunctionNov 27, 2024Fracture; Fracture
IT WAS REPORTED THAT THE CINCHLOCK FLEX IMPLANT FAILED TO RELEASE THE NITINOL WIRE FROM THE IMPLANT UPON DEPLOYMENT. THERE WAS A SMALL AMOUNT OF THE WIRE LEFT IN THE IMPLANT WHICH MAY OR MAY NOT BECOME AN ISSUE GOING FORWARD.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 20799594 ↗InjuryNov 27, 2024Fracture; Fracture
IT WAS REPORTED THAT THE CINCHLOCK FLEX IMPLANT FAILED TO RELEASE THE NITINOL WIRE FROM THE IMPLANT UPON DEPLOYMENT. THERE WAS A SMALL AMOUNT OF THE WIRE LEFT IN THE IMPLANT WHICH MAY OR MAY NOT BECOME AN ISSUE GOING FORWARD.
Patient problems: Foreign Body In Patient
MAUDE report 20799352 ↗MalfunctionNov 27, 2024Fracture; Fracture
IT WAS REPORTED THAT THE CINCHLOCK FLEX IMPLANT FAILED TO RELEASE THE NITINOL WIRE FROM THE IMPLANT UPON DEPLOYMENT. THERE WAS A SMALL AMOUNT OF THE WIRE LEFT IN THE IMPLANT WHICH MAY OR MAY NOT BECOME AN ISSUE GOING FORWARD.
Patient problems: Foreign Body In Patient
MAUDE report 20799330 ↗MalfunctionNov 7, 2024Break; Fracture; Break; Fracture
IT WAS REPORTED THAT THE PULL WIRE REMAINED IN THE ANCHOR. THE PULL WIRE WAS ABLE TO BE REMOVED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 20630615 ↗MalfunctionNov 7, 2024Fracture; Fracture
IT WAS REPORTED THAT THE PULL WIRE REMAINED IN THE ANCHOR. THE PULL WIRE WAS ABLE TO BE REMOVED.
Patient problems: Insufficient Information
MAUDE report 20626467 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page