CinchLock Flex CAT02643Recalls & reported problems
Stryker Corporation · FG, CINCHLOCK FLEX KNOTLESS ANCHOR WITH INSERTER · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Stryker CinchLock Flex knotless anchor is used with an inserter to fasten soft tissue to bone. Most of the 58 reports describe the anchor fracturing or breaking during placement, sometimes leaving wire or anchor fragments in the bone that could not be removed; 17 involved injuries and no deaths were described. One open recall from January 2025 covers complaints of the pullwire breaking so a piece stays inside the anchor.
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
- 58
- Deaths reported
- 0
- Injuries reported
- 17
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 07613327123661), received between Aug 28, 2018 and Mar 10, 2026 — classified as 17 injuries, 41 malfunctions.
The most frequently reported specific device problem is “Fracture” (26 reports).
1 FDA recall record name this device's 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- 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 · FDA record ↗
Most reported problems
Device problems
- Fracture26
- Break23
- 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 Patient8
- Device Embedded In Tissue or Plaque2
- No Information1
Recent adverse event reports
The 25 most recent of 58 reports, 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 ↗MalfunctionNov 6, 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 20624269 ↗MalfunctionNov 5, 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 20615952 ↗MalfunctionOct 30, 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 20570717 ↗MalfunctionOct 30, 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 20570456 ↗MalfunctionOct 30, 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 20570450 ↗MalfunctionOct 30, 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 20570385 ↗MalfunctionOct 30, 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 20570310 ↗MalfunctionOct 24, 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 20528056 ↗MalfunctionOct 24, 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 20526838 ↗MalfunctionAug 28, 2024Fracture; Material Fragmentation; Fracture; Material Fragmentation
IT WAS REPORTED THAT THE PULL WIRE REMAINED IN THE ANCHOR AND THE EXPANSION CYLINDER BROKE. THE PULL WIRE WAS ABLE TO BE REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20091805 ↗
Other FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE devices
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- 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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