Invue Solid Driver — Class II medical device recall Z-1957-2013
Terminated recall by SpineFrontier, Inc., reported 2013-08-21, distributed in DC, MA, OK. The nipple of the tipped driver broke off when surgeons were attempting to insert the screw.
| Recall number | Z-1957-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SpineFrontier, Inc., Beverly, MA, United States |
| Recall initiated | 2012-05-09 |
| Classified | 2013-08-13 |
| Reported by FDA | 2013-08-21 |
| Terminated | 2014-01-10 |
| Distributed | DC, MA, OK |
| Quantity | 9 |
| Lot numbers | 011836-0001, 011981-001 |
| Model numbers | 11-70083 |
Product
Invue Solid Driver, Tipped, AO. Part Number: 11-70083. Allows the user to retain the screw when changing axis of insertion during fixation of spinal intervertebral.
Reason for recall
The nipple of the tipped driver broke off when surgeons were attempting to insert the screw.
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-1957-2013. 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.