SybronEndo Elements Obturation Unit Recalled for Missing Safety Label
SybronEndo is recalling 3,615 Elements Obturation Units because a required Canadian safety caution label was accidentally omitted from the device and its power cord.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II due to a labeling error (missing cautionary statement). Per the rubric, minor labeling errors and voluntary precautionary recalls without reported injuries fall under the Moderate severity level.
Plain-English summary
SybronEndo has issued a recall for the Elements Obturation Unit and its Replacement A/C Power Cord. The recall was initiated because a Canadian Standards Association (CSA)-directed cautionary statement label was inadvertently omitted from the product.
The affected units were distributed worldwide, including in the United States, Canada, and numerous other countries. The specific serial numbers involved in this recall range from 91-17011 to 91-19095 and 91-20889 to 91-22339. The device is intended for use in dental endodontic root canal treatment to provide heat for testing tooth response, tissue cauterization, and gutta percha manipulation.
Consumers and dental professionals should check their inventory for the affected serial numbers. The recall is classified as Class II by the FDA, indicating that the omission of the safety label could result in temporary or medically reversible health consequences.
The recalled product
- 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
- Manufacturer
- Ormco/Sybronendo
- Hazard
- Affected units
- 3,615
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot/Serial Numbers: 91-17011 to 91-19095
- 91-20889 to 91-22339
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Ormco/Sybronendo under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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