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

Recall Z-1167-2018 — SwishTapered Implant Intended for use in support for fixed bridgework.

U.S. FDA — Device Enforcement · United States · 2018-01-19 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1167-2018
Date of alert
2018-01-19
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Implant Direct Sybron Manufacturing, LLC
Product category
device
Product type
Devices
Reported risk: The extender that is packaged with the SwishTapered" and SwishPlus" Implant may have been packaged in the incorrect position (upside down in the plastic retainer).
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.

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