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Terminated

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

FDA Recall Z-1083-2016 · Posted None

Recalling FirmOrmco/Sybronendo
Recall StatusTerminated
Product CodeEKM
Date Initiated2016-02-08
Date Terminated2016-08-30
Product Quantity5,568 units total (2,070 units in US)

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.

Firm Action

An Urgent Medical Device Recall letter dated February 8, 2016 was sent to all customers. The letter identified the affected product, problem and actions to be taken. Customers are instructed to complete and fax back the enclosed acknowledgement form to 909-962-5605 to confirm receipt of the recall notification .

Root Cause

Error in labeling

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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