FDA Device recall Z-1482-2013
Straight Impactor - Dorado IBC, Part Number: SI02140
- FDA Device
- Class II
- terminated
- Published 2013-06-12
On 2013-06-12 the FDA classified a Class II recall of Straight Impactor - Dorado IBC, Part Number: SI02140 by Spinefrontier, citing during two separate occasions an impactor plate on the handle broke off while being struck by a mallet.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1482-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2008-05-10 |
| Published | 2013-06-12 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Spinefrontier |
| Distribution | US |
Product
Straight Impactor - Dorado IBC, Part Number: SI02140. The device is used to position implants after they have been inserted into the disc space during implantation of intervertebral body fusion devices.
Reason
During two separate occasions an impactor plate on the handle broke off while being struck by a mallet.
Identifiers
| code_info | Lot number: 20856 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1482-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.