Ormco/Sybronendo: Medical Device Recall in 2016 - (Recall #: Z-1083-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: February 8, 2016

Date Posted: March 16, 2016

Recall Number: Z-1083-2016

Event ID: 73293

Reason for Recall:

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.

Status: Terminated

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

Code Information:

GE15011637

Distribution Pattern:

Worldwide Distribution - US Nationwide and the countries of Canada, Australia, Mexico, Europe, Hong Kong, MY, IN, JP, ID, SG, TH

Voluntary or Mandated:

Voluntary: Firm initiated