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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 67388

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
December 18, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Stryker Spine

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

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Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-1086-2014
Recall number
Z-1086-2014
Initiated
December 18, 2013
Classification
Class II
Status
Terminated
Recalling firm
Stryker Spine
Quantity
21 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Stryker has received complaints from customers relating to fracture along the weld that binds the handle to the shaft of the static inserter.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

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Inspect official wording and provenance

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.

Code information

D109140 Catalog # IS3009AVS Lot Serial # 3664, 3759, 3843, 3913, 4079, 4195 and 4242

Distribution pattern

US Nationwide Distribution

Field note

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