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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 65968

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

Open FDA event record

Event summary

Timeline bucket
May 14, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Spine Wave, Inc.

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

StaXx¿ IB Convex Expandable Implant (25 x 12 x 9 mm), Intervertebral Fusion Device, Lumbar; Catalog Number 11 -1902. Indicated for intervertebral body fusion procedures in skeletally mature patients.

Z-2187-2013
Recall number
Z-2187-2013
Initiated
May 14, 2013
Classification
Class II
Status
Terminated
Recalling firm
Spine Wave, Inc.
Quantity
17 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A component Superior endplate manufactured from a different polymer than specified

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A component Superior endplate manufactured from a different polymer than specified

Code information

Lot Numbers: 272L08 and 272L09

Distribution pattern

Distributed in the states of FL and OR.