Reported Jun 26, 2013 · Terminated
SybronEndo Elements Obturation Unit; REF 973-0322; SN 91-1234; 2005-10; SybronEndo, 1332 S. Lone Hill Ave. Glendora, CA…
Ormco/Sybronendo
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ormco/Sybronendo · 1332 S Lone Hill Ave · Glendora, CA · 91740-5339
Is this the product you have?
6 of 6 products
| Model / number | Product as published |
|---|---|
| — | SybronEndo Elements Obturation Unit |
973-0322 | — |
| — | SN 91-1234 |
| — | 2005-10 |
| — | SybronEndo, 1332 S. Lone Hill Ave. Glendora, CA 91740 |
| — | EU Rep: Kerr Italia, S.r.l, Via Passanti, 332, 1-84018 Scafati (SA), Italy The intended use of the Elements Obturation Unit and Replacement A/C Power Cord is to provide continuous heat at the tip of the dental instrument to test tooth response to thermal stimulus, for tissue cauterization and coagulation and to backfill and down pack gutta percha during endodontic root canal treatment. |
- Lot codes and dates
- Lot/Serial Numbers
91-17011 to 91-1909591-20889 to 91-22339
- Lot/Serial Numbers
- Amount recalled
- 3615 units total
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
A recall has been issued by SybronEndo because a Canadian Standards Association (CSA)-directed cautionary statement label was inadvertently omitted from the Elements Obturation Unit and its Replacement A/C Power Cord.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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