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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 73180

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, 2015
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

Stryker Aero-AL Impaction handle Catalog Number 48921007. Stryker Spine Manufactured by : Stryker Spine SAS France Used to facilitate insertion of the Aero-AL cage into the disc space.

Z-0828-2016
Recall number
Z-0828-2016
Initiated
December 18, 2015
Classification
Class II
Status
Terminated
Recalling firm
Stryker Spine
Quantity
31 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Reported jamming of the impaction handle when assembled to the Inserter guide at the threads.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reported jamming of the impaction handle when assembled to the Inserter guide at the threads.

Code information

Lot #144933, 14D252, and 14D253.

Distribution pattern

Nationwide Distribution