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

Recall Z-0422-2016 — Flexible Screw Driver SJ706R; Non Sterile; B Braun; Aesculap; Aesculap AG These instruments are intended for use during the implantations of the A-Space SIBD and Arcadius XP L systems.

U.S. FDA — Device Enforcement · United States · 2015-11-10 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0422-2016
Date of alert: 2015-11-10
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Aesculap, Inc.
Product category: device
Product type: Devices

Reported risk: The flexible shaft of the instruments may break during orthopedic spinal surgery. There is a risk of a delay in surgery or that a fragment from the shaft could be left in a patient.

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-0422-2016 — Flexible Screw Driver SJ706R; Non Sterile; B Braun; Aesculap; Aesculap AG These instruments are intended for use during the implantations of the A-Space SIBD and Arcadius XP L systems.

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