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

Recall Z-1367-2021 — Consist of a distal connection mechanism (either standard Terumo Ball Quick Connect or Terumo Shaft Quick Connect), an articulating arm with links, a handle for providing cable tension, and a mechanism to mount the device to a sternal retractor.

U.S. FDA — Device Enforcement · United States · 2021-03-02 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1367-2021
Date of alert: 2021-03-02
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Terumo Cardiovascular Systems Corporation
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00699753450950

Reported risk: There is a potential for the stainless steel locking plates on the device's sternal retractor locking mechanism to fracture.

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.

Recall Z-1367-2021 — Consist of a distal connection mechanism (either standard Terumo Ball Quick Connect or Terumo Shaft Quick Connect), an articulating arm with links, a handle for providing cable tension, and a mechanism to mount the device to a sternal retractor.

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