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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 63433

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

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Event summary

Timeline bucket
April 18, 2012
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

Bacterin International, Inc., Osteoselect Demineralized Bone Matrix DMB Putty; Graft ID# B090056-664 Donor# B090056 2.5cc Expiration Date: 12/25/2011; LBL 210-0010-1 REV: 040109; and Graft ID# B090056-675. Bone void filler for voids or gaps in bone. Indicated for treatment of surgically created osseous defects. On 07/12/2012 an additional expired product was discovered by a Bacterin sales rep. B100078-908 with expiration date 04/27/2012

Z-0800-2013
Recall number
Z-0800-2013
Initiated
April 18, 2012
Classification
Class II
Status
Terminated
Quantity
3 packages each containing 2.5cc of putty

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Expired product was shipped to two customers.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Incorrect or no expiration date

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Expired product was shipped to two customers.

Code information

Graft ID# B090056-664 and Graft ID#: B090056-675, both with Donor# B090056 and Expiration Date: 12/25/2011. A thrid graft with ID# B100078-908 expiration date 04/27/2012 was added to the recall 7/12/2012.

Distribution pattern

Nationwide Distribution in TX , GA and CA.