Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

TF Adaptive Gutta Percha Point Size SM3 50pk Recalled by Ormco/Sybronendo Due to Ormco Corporation is recalling the TF Adaptive Gutta...

Date: February 8, 2016
Company: Ormco/Sybronendo
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Ormco/Sybronendo directly.

Affected Products

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

Quantity: 5,568 units total (2,070 units in US)

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Ormco/Sybronendo

Ormco/Sybronendo has 16 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report