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

Recall Z-1208-2023 — SciCan STATIS SL S10001 Dental Handpieces-Intended for the removal of carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations, restorations and for polishing teeth. Model Number: S10001

U.S. FDA — Device Enforcement · United States · 2023-01-20 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1208-2023
Date of alert
2023-01-20
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Coltene Whaledent Inc
Product category
device
Product type
Devices
Reported risk: Screw connection between the turbine head and the push button may loosen and fall off during the treatment, and increase the risk of swallowing or inhaling part of the turbines head or the push button
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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