Exact FDA event identifier

Event 74583

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

Open FDA event record

Event summary

Timeline bucket: July 01, 2016
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Integra LifeSciences Corp.

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

Integra External Fixation System Rocker Bottom Model # 12225400. For use in the treatment of bone conditions amenable to treatment by the use of external fixation.

Z-2296-2016

Recall number: Z-2296-2016
Initiated: July 01, 2016
Classification: Class II
Status: Terminated
Recalling firm: Integra LifeSciences Corp.
Quantity: 27 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The silicone insert embedded in the rocker bottom has the potential to become dislodged or loose from the rocker bottom mold.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The silicone insert embedded in the rocker bottom has the potential to become dislodged or loose from the rocker bottom mold.

Code information

Lot # PN625.

Distribution pattern

Distributed in the US to the states of FL, VA, OK, CO, DC, and IN.