FDA Device recall Z-1957-2013
Invue Solid Driver, Tipped, AO. Part Number: 11-70083
- FDA Device
- Class II
- terminated
- Published 2013-08-21
On 2013-08-21 the FDA classified a Class II recall of Invue Solid Driver, Tipped, AO. Part Number: 11-70083 by Spinefrontier, citing the nipple of the tipped driver broke off when surgeons were attempting to insert the screw.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1957-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-05-09 |
| Published | 2013-08-21 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Spinefrontier |
| Distribution | DC, MA, OK |
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
The nipple of the tipped driver broke off when surgeons were attempting to insert the screw.
Identifiers
| code_info | Lot Number: 011836-0001, 011981-001 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1957-2013%22
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