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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 64991

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

Open FDA event record

Event summary

Timeline bucket
May 10, 2008
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
SpineFrontier, 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

Straight Impactor - Dorado IBC, Part Number: SI02140. The device is used to position implants after they have been inserted into the disc space during implantation of intervertebral body fusion devices.

Z-1482-2013
Recall number
Z-1482-2013
Initiated
May 10, 2008
Classification
Class II
Status
Terminated
Recalling firm
SpineFrontier, Inc.
Quantity
10

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During two separate occasions an impactor plate on the handle broke off while being struck by a mallet.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During two separate occasions an impactor plate on the handle broke off while being struck by a mallet.

Code information

Lot number: 20856

Distribution pattern

Worldwide distribution: US (nationwide) to states of: CO, MA, and TX; and country of: Jamaica.