Exact FDA event identifier

Event 64486

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

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Event summary

Timeline bucket: February 21, 2013
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Bacterin International, 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

OsteoSelect DBM Putty Product Usage: Orthopedic bone filler

Z-1138-2013

Recall number: Z-1138-2013
Initiated: February 21, 2013
Classification: Class II
Status: Terminated
Recalling firm: Bacterin International, Inc.
Quantity: 165

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The firm's retesting procedure was not validated.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm's retesting procedure was not validated.

Code information

B100164 and B110115

Distribution pattern

USA Nationwide Distribution