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

Recall Z-1634-2016 — CinchLock SS Knotless Anchor with Inserter; Model number CAT02462; Orthopedic: The Pivot CinchLock SS Knotless Anchor (CAT02462) and Pivot CinchLock Flex Knotless Anchor (CAT02463) are non-degradable implant devices intended for the fixation of soft tissue to bone. Used for repair of hip, shou

U.S. FDA — Device Enforcement · United States · 2016-04-12 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1634-2016
Date of alert: 2016-04-12
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Stryker Corporation
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 15120801

Reported risk: Stryker Endoscopy is recalling the CinchLock SS Knotless Anchor with Inserter and the CinchLock Flex Anchor with Inserter after 13 reports of s of an internal wire breaking upon deployment of the anchor.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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.

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