CLASS II Device recall · Reported 9 Dec 2015 · FDA Enforcement Report
Copper NiTi Preformed Archwires recalled by Ormco/Sybronendo
Ormco/Sybronendo is recalling Copper NiTi Preformed Archwires, distributed nationwide in the US. The recall was initiated on 4 Nov 2015 and the FDA has classified it as Class II.
Check your package
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-0343-2016
- FDA event ID
- 72590
- Recalling firm
- Ormco/Sybronendo, Glendora, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Nov 2015
- FDA classified
- 30 Nov 2015
- Reported
- 9 Dec 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Temperature Abuse
- Device type
- Masks, Gloves & PPE
Timeline
| 4 Nov 2015 | Recall initiated by company | |
| 30 Nov 2015 | Classified by FDA | +26 days |
| 9 Dec 2015 | Published in enforcement report | +9 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 Copper NiTi Preformed Archwires because the product transformation temperature as listed on the labeling is incorrect.
Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.
Product as listed by the FDA
Copper NiTi Preformed Archwires; Copper NiTi 40 BAF .016X.022 LO Pk10, Part No. 211-0952. Intended to provide tooth movement.
Where it was distributed
Distributed US (nationwide) and the countries of Canada, Japan, Mexico, Russia, and Peru.
Questions about this recall
Is Copper NiTi Preformed Archwires recalled?
Yes. Ormco/Sybronendo recalled Copper NiTi Preformed Archwires on 4 Nov 2015. The recall is Class II and its status is Terminated. Recall number Z-0343-2016.
Why was it recalled?
Ormco Corporation is recalling Copper NiTi Preformed Archwires because the product transformation temperature as listed on the labeling is incorrect.
Which lots are affected?
Lot No. 21538339
Where was it sold?
Distributed US (nationwide) and the countries of Canada, Japan, Mexico, Russia, and Peru.
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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