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

Recall Z-1083-2016 — TF Adaptive Gutta Percha Point Size SM3 50pk, Part No. 815-1541 Intended to fill a endontontically obturated root canal treatment

U.S. FDA — Device Enforcement · United States · 2016-02-08 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1083-2016
Date of alert
2016-02-08
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Ormco/Sybronendo
Product category
device
Product type
Devices
Reported risk: Ormco Corporation is recalling the TF Adaptive Gutta Percha Point Size SM3-50pk because the inner generic label is identified as ML3. The products outer package is identified as SM3 which matches the product inside.
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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