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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80971

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

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Event summary

Timeline bucket
August 13, 2018
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.

How coverage and grouping work

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

AVS Aria Cage, Catalog Number 48753212 Product Usage: The Stryker Spine AVS¿ ARIA 1M PEEK Spacers are intervertebral body fusion devices indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1 . The AVS¿ ARIA TM PEEK Spacers are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine.

Z-0092-2019
Recall number
Z-0092-2019
Initiated
August 13, 2018
Classification
Class II
Status
Terminated
Recalling firm
Stryker Spine
Quantity
5

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The anterior and posterior markers on the cage were on the incorrect/opposite sides of the cage.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The anterior and posterior markers on the cage were on the incorrect/opposite sides of the cage.

Code information

Lot Number 7HX

Distribution pattern

US Nationwide in the states: CA, FL, GA, MI, MN, NJ, NM, and OR

Field note

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