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

Recall Z-0364-2020 — Implant Direct, REF: 833708, Legacy 2 Implant, Surface: HA, 3.7mmD x 8mmL, 3.5mmD Platform, RxOnly, Sterile R, Made in USA Dental Implants

U.S. FDA — Device Enforcement · United States · 2019-08-09 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0364-2020
Date of alert
2019-08-09
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: A QA inspection confirmed that a Healing Collar (Part number 8735-15) was packaged instead of the Implant ordered.
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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