Z-1086-2014Class II

Specialty Straight Static Inserter Assembly

Name: Z-1086-2014 Specialty Straight Static Inserter Assembly
Creator: Stryker Spine
Published: 2013-12-18
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2013-12-18 / Terminated / root cause: design

FDA source

Stryker Spine began a recall of 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... on 2013-12-18. FDA classified it as Class II and gives the reason as "Stryker has received complaints from customers relating to fracture along the weld that binds the handle to the shaft of the static inserter". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1086-2014
Classification: Class II
Status: Terminated
Initiated: 2013-12-18
Posted: 2014-02-25
Terminated: 2014-08-25
Recalling firm: Howmedica Osteonics Corp
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.
Product code: LXH Orthopedic Manual Surgical Instrument
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.
Root cause tag: design
FDA root cause: Device Design
Action: Stryker sent Urgent Medical Device Removal Notification letter and to their customers via email on 12/18/2013. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine their inventory, return affected product using enclosed pre-paid mailing label, complete Customer Response Form and fax to Regulatory Compliance at 855-632-9049 or mail it to [email protected]. For questions call 201-760-8287, 201-760-8298 or 201-760-8041.
Quantity in commerce: 21 units
Distribution: US Nationwide Distribution
Product codes and lots: D109140 Catalog # IS3009AVS Lot Serial # 3664, 3759, 3843, 3913, 4079, 4195 and 4242

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1086-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1086-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-05	2014-02-24

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)