SybronEndo Elements Obturation Unit — Class II medical device recall Z-1544-2013
Terminated recall by Ormco/Sybronendo, reported 2013-06-26, distributed nationwide. A recall has been issued by SybronEndo because a Canadian Standards Association (CSA)-directed cautionary stat
| Recall number | Z-1544-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ormco/Sybronendo, Glendora, CA, United States |
| Recall initiated | 2013-01-17 |
| Classified | 2013-06-14 |
| Reported by FDA | 2013-06-26 |
| Terminated | 2013-11-07 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BE, CA, CH, CN, CY, CZ, DE, EE, EG, ES, FI, FR, GB, GR, HK, IN, IS, IT, JP, KW, LB, LV, MY, NL, NZ, PK, PL, RO, RU, SA, SE, SG, TH, TR, UA |
| Quantity | 3,615 units |
| Reason classes | labeling |
| Serial numbers | 91-17011, 91-19095, 91-20889, 91-22339 |
| Model numbers | 973-0322 |
Product
SybronEndo Elements Obturation Unit; REF 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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1544-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.