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

Recall Z-1327-2021 — Stryker Sustainability Solutions REF HARH36 Ethicon Endo-Surgery, Inc. Harmonic ACE +7, Shears with Advanced Hemostasis 5mm Diameter x 36cm - Product Usage: indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to

U.S. FDA — Device Enforcement · United States · 2021-01-19 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1327-2021
Date of alert: 2021-01-19
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Stryker Sustainability Solutions
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 07613327346251

Reported risk: Product was distributed without receiving regulatory clearance.

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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