Spine Frontier Inspan compressors Part Number: 11-60004 — Class II medical device recall Z-0412-2013
Terminated recall by SpineFrontier, Inc., reported 2012-11-28, distributed nationwide. Inspan Compressors may break at weld causing a loss of compression
| Recall number | Z-0412-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SpineFrontier, Inc., Beverly, MA, United States |
| Recall initiated | 2012-08-28 |
| Classified | 2012-11-21 |
| Reported by FDA | 2012-11-28 |
| Terminated | 2015-06-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | MX |
| Quantity | 17 units |
| Reason classes | device malfunction |
| Lot numbers | SFP02323, SFP02323R, SFP02323RR |
| Model numbers | 11-60004 |
Product
Spine Frontier Inspan compressors Part Number: 11-60004. Inspan compressors provide pressure to drive spikes of Inspan implants into the spinous process bone, resulting in fixation of the implant.
Reason for recall
Inspan Compressors may break at weld causing a loss of compression
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-0412-2013. 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.