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

Recall Z-1485-2018 — Genesis Surgical Cassette Tapered Implants are intended for placement following natural tooth loss or for immediate placement into an extraction socket

U.S. FDA — Device Enforcement · United States · 2018-03-13 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1485-2018
Date of alert
2018-03-13
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Keystone Dental Inc
Product category
device
Product type
Devices
Reported risk: The surgical cassette contained extra-large white grommets making the 3.8 mm and 6.5mm dental burrs wobble within the grommets in the surgical cassette.
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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