CLASS II Device recall · Reported 16 Mar 2016 · FDA Enforcement Report

TF Adaptive Gutta Percha Point Size SM3 recalled by Ormco/Sybronendo

Ormco/Sybronendo is recalling TF Adaptive Gutta Percha Point Size SM3, distributed nationwide in the US. The recall was initiated on 8 Feb 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesGE15011637

Quantity recalled5,568 units total (2,070 units in US)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1083-2016
FDA event ID: 73293
Recalling firm: Ormco/Sybronendo, Glendora, CA
Classification: Class II
Status: Terminated
Recall initiated: 8 Feb 2016
FDA classified: 8 Mar 2016
Reported: 16 Mar 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

8 Feb 2016	Recall initiated by company
8 Mar 2016	Classified by FDA	+29 days
16 Mar 2016	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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

Where it was distributed

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

Nationwide Idaho Indiana

Questions about this recall

Is TF Adaptive Gutta Percha Point Size SM3 recalled?

Yes. Ormco/Sybronendo recalled TF Adaptive Gutta Percha Point Size SM3 on 8 Feb 2016. The recall is Class II and its status is Terminated. Recall number Z-1083-2016.

Why was it recalled?

Which lots are affected?

GE15011637

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Ormco/Sybronendo

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