Z-1083-2016Class II

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

Name: Z-1083-2016 TF Adaptive Gutta Percha Point Size SM3 50pk, Part No. 815-1541 Intended to fill a endontontically obturated...
Creator: Ormco/Sybronendo
Published: 2016-02-08
License: https://open.fda.gov/license/

Ormco/Sybronendo / initiated 2016-02-08 / Terminated / root cause: labeling and UDI

FDA source

Ormco/Sybronendo began a recall of TF Adaptive Gutta Percha Point Size SM3 50pk, Part No. 815-1541 Intended to fill a endontontically obturated root canal treatment on 2016-02-08. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1083-2016
Classification: Class II
Status: Terminated
Initiated: 2016-02-08
Posted: 2016-03-08
Terminated: 2016-08-30
Recalling firm: Ormco/Sybronendo
Product: TF Adaptive Gutta Percha Point Size SM3 50pk, Part No. 815-1541 Intended to fill a endontontically obturated root canal treatment
Product code: EKM Gutta-Percha
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.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
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 .
Quantity in commerce: 5,568 units total (2,070 units in US)
Distribution: Worldwide Distribution - US Nationwide and the countries of Canada, Australia, Mexico, Europe, Hong Kong, MY, IN, JP, ID, SG, TH
Product codes and lots: GE15011637

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1083-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1083-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-16	2016-03-08

Product code EKM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)