FDA Device recall Z-1086-2014
Specialty Straight Static Inserter Assembly Product Usage: This instrument is a part of the Navigator product brand . It is used for implan…
- FDA Device
- Class II
- terminated
- Published 2014-03-05
On 2014-03-05 the FDA classified a Class II recall of Specialty Straight Static Inserter Assembly Product Usage: This instrument is a part of the Navigator product brand . It is used for implan… by Stryker Spine, citing stryker has received complaints from customers relating to fracture along the weld that binds the handle to the shaft of the static inserter.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1086-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-12-18 |
| Published | 2014-03-05 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Stryker Spine |
| Distribution | US |
Product
Specialty Straight Static Inserter Assembly Product Usage: This instrument is a part of the Navigator product brand . It is used for implant insertion in to the disc space. The AVS navigator Peek Spacer System offers implants that are interbody fusion devices intended for use as an aid in spinal fixation. These hollow implants are offered in a variety of lengths, heights and lordotic angles designed to adapt to different patient anatomies. They have serrations on the superior and inferior surfaces designed for multidirectional fixation and ergonomically shaped anterior edges and flat posterior edges.
Reason
Stryker has received complaints from customers relating to fracture along the weld that binds the handle to the shaft of the static inserter.
Identifiers
| code_info | D109140 Catalog # IS3009AVS Lot Serial # 3664, 3759, 3843, 3913, 4079, 4195 and 4242 |
|---|
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-1086-2014%22
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