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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 75904

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

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Event summary

Timeline bucket
December 05, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Acumed LLC

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

OPT Croutons is a synthetic bone substitute designed for the repair of bony defects and is made of pure beta-tricalcium phosphate. The tricalcium phosphate is a soluble calcium phosphate salt.

Z-1019-2017
Recall number
Z-1019-2017
Initiated
December 05, 2016
Classification
Class II
Status
Terminated
Recalling firm
Acumed LLC
Quantity
83 units distributed in the US

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
inadequate documentation of the sterilization

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

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Inspect official wording and provenance

Reason for recall

OPT Croutons, part number 65-0210-S, is recalled due to the result of inadequate documentation of the sterilization dose used in production. Product sterilized at the site did not receive the minimum dose required per the new performance qualification.

Code information

lot 549/12.001. Part number 65-0210-S.

Distribution pattern

distributed in FL, IN, KS, MI, MO, NE, OH, PA, TX and Peurto Rico.