FDA Device recall Z-1666-2013
InSpan Inserter, Right Assembly
- FDA Device
- Class II
- terminated
- Published 2013-07-10
On 2013-07-10 the FDA classified a Class II recall of InSpan Inserter, Right Assembly by Spinefrontier, citing potential for set screw to be come deformed.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1666-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-05-07 |
| Published | 2013-07-10 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Spinefrontier |
| Distribution | US |
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
Potential for set screw to be come deformed.
Identifiers
| code_info | Right Assembly: 43097, 44614, 43097R; Left Assembly: 43098, 44615, 43098R |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1666-2013%22
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