InSpan Inserter — Class II medical device recall Z-1666-2013
Terminated recall by SpineFrontier, Inc., reported 2013-07-10, distributed nationwide. Potential for set screw to be come deformed.
| Recall number | Z-1666-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SpineFrontier, Inc., Beverly, MA, United States |
| Recall initiated | 2013-05-07 |
| Classified | 2013-07-04 |
| Reported by FDA | 2013-07-10 |
| Terminated | 2016-01-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | DO, PA |
| Quantity | 61 individual |
Product
InSpan Inserter, Right Assembly; InSpan Inserter, Left Assembly Product Usage: Inserters are stainless steel instruments that have an inner shaft. The left and right inserters are used in combination with each other to place the implants into the body. Inserters are used to install the InSpan Spinous Plate System for the purpose of achieving supplemental fixation.
Reason for recall
Potential for set screw to be come deformed.
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-1666-2013. 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.