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

Recall Z-0410-2021 — END RING 15MM DIA/0 DEG (TI) Product Number: 495.386 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is best suited to the patient s individua

U.S. FDA — Device Enforcement · United States · 2020-09-21 · Class III

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0410-2021
Date of alert: 2020-09-21
Country / jurisdiction: United States
Risk level: Class III
Risk type: recall
Brand: Synthes (USA) Products LLC
Product category: device
Product type: Devices

Reported risk: Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"

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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