Device recall
Z-1544-2013: SybronEndo Elements Obturation Unit; REF 973-0322; SN 91-1234; 2005-10…
FDA device recall · Class II · Ormco/Sybronendo
Key facts
| Recall number (Z-number) | Z-1544-2013 |
|---|---|
| Recall event | 64216 |
| 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… |
| Product code | EKR |
| Recalling firm | Ormco/Sybronendo |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 7, 2013 |
| 510(k) numbers | K031664 |
| FEI number | 2016150 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database