Fastener, Fixation, Nondegradable, Soft Tissue

Reports per year

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

• 2025-10-17Open, ClassifiedUnder Investigation by firm

  BIOMET ZipTight, Acute AC Joint Implant, Single Ziploop , Model/Catalog Number: 904834; Fixation System for AC Joint Repair

  There is a potential for a missing slotted button assembly in one lot of ZipTight, Acute AC Joint Implant, Single Ziploop

• 2025-09-23Open, ClassifiedUnder Investigation by firm

  Juggerknot Mini Soft Anchors, Model/Catalog Number: 912080

  The outer carton box label is for the JuggerKnot 1.0mm Mini products. However, the products within the carton are JuggerKnot 1.4mm Short devices.

• 2025-03-12Open, ClassifiedUnder Investigation by firm

  Stryker CinchLock Flex Knotless Anchor with Inserter and Suture, REF CAT02643, Sterile EO, Rx Only MR Safe CE 0197

  Increase in complaints concerning "pullwire" breakage that may result in the broken pullwire remaining in the anchor implant body after deployment.

• 2024-11-29Open, ClassifiedPackage design/selection

  BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.

  Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device.

• 2023-12-08Open, ClassifiedComponent design/selection

  Iconix Knotless 1.4mm Anchor with XBraid S (Blue/Black) REF 3911-714-520 Iconix Knotless 1.4mm Anchor with XBraid S (Black/White) REF 3911-714-521 The Iconix Knotless anchors are intended to be used for soft-tissue to bone fixation in the foot, ankle, knee, hip, hand, wrist, elbow and shoulder.

  Use of a 1.4 drill in hard bone conditions caused increased insertion forces leading to subsequent failures of the inserter, when the inserters bend, it may also move off the drill hole location leading to damage of the suture construct during insertion. Suture damage may lead to suture breaks during use.

• 2023-09-28Open, ClassifiedUnknown/Undetermined by firm

  Cinchlock SS Knotless Anchor Inserter, Part Number CAT02462

  Expired Product distributed

• 2023-07-03Open, ClassifiedDevice Design

  BETTA LINK SR KNOTLESS IMPLANT KIT-Intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon disruption or to assist in reconstruction surgeries. Part Number:110045154

  Drill guides might bend when axial forces are applied by surgeon during procedure and result in potential metal shavings due to friction with the drill bit.Risk to patients includes potential of injury.

• 2023-07-03Open, ClassifiedDevice Design

  BETTA LINK LG KNOTLESS IMPLANT KIT-Intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon disruption or to assist in reconstruction surgeries. Part Number: 110045160

  Drill guides might bend when axial forces are applied by surgeon during procedure and result in potential metal shavings due to friction with the drill bit.Risk to patients includes potential of injury.

• 2022-09-22Open, ClassifiedDevice Design

  Grappler Suture Anchor, Titanium, 3.0 x 10mm, Sterile Kit, REF: P44-110-3010-SK, for use within the Grappler Suture Anchor System

  Suture anchor may break upon insertion, which could lead to potential debris in patient, and delays in surgery.

• 2020-12-17TerminatedProcess control

  Titanium IFS, Item number 909680 - Product Usage: Bone to bone fixation.

  Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.