Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1328-2025 — Stryker CinchLock Flex Knotless Anchor with Inserter and Suture, REF CAT02643, Sterile EO, Rx Only MR Safe CE 0197

U.S. FDA — Device Enforcement · United States · 2025-01-29 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1328-2025
Date of alert
2025-01-29
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Stryker Corporation
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
07613327123661
Reported risk: Increase in complaints concerning "pullwire" breakage that may result in the broken pullwire remaining in the anchor implant body after deployment.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.