Straight Impactor — Class II medical device recall Z-1482-2013
Terminated recall by SpineFrontier, Inc., reported 2013-06-12, distributed nationwide. During two separate occasions an impactor plate on the handle broke off while being struck by a mallet.
| Recall number | Z-1482-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SpineFrontier, Inc., Beverly, MA, United States |
| Recall initiated | 2008-05-10 |
| Classified | 2013-06-05 |
| Reported by FDA | 2013-06-12 |
| Terminated | 2014-10-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | JM |
| Quantity | 10 |
| Lot numbers | 20856 |
| Model numbers | SI02140 |
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 for recall
During two separate occasions an impactor plate on the handle broke off while being struck by a mallet.
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-1482-2013. 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.