Specialty Straight Static Inserter Assembly Product Usage: This… — Class II medical device recall Z-1086-2014
Terminated recall by Stryker Spine, reported 2014-03-05, distributed nationwide. Stryker has received complaints from customers relating to fracture along the weld that binds the handle to th
| Recall number | Z-1086-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Spine, Allendale, NJ, United States |
| Recall initiated | 2013-12-18 |
| Classified | 2014-02-24 |
| Reported by FDA | 2014-03-05 |
| Terminated | 2014-08-25 |
| Distributed | Nationwide (US) |
| Quantity | 21 units |
| Reason classes | device malfunction |
| Serial numbers | 3664, 3759, 3843, 3913, 4079, 4195, 4242 |
| Model numbers | IS3009AVS |
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 for recall
Stryker has received complaints from customers relating to fracture along the weld that binds the handle to the shaft of the static inserter.
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-1086-2014. 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.