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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85400

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

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Event summary

Timeline bucket
April 01, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Howmedica Osteonics 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

Cortoss Bone Augmentation Material, Catalog Nos. 2101-0005 and 2101-0010

Z-1900-2020
Recall number
Z-1900-2020
Initiated
April 01, 2020
Classification
Class II
Status
Terminated
Recalling firm
Howmedica Osteonics Corp.
Quantity
115

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Shipments were transported outside of the required refrigerated temperature conditions. Potential hazards if used include nerve damage resulting in paralysis and increased potential for embolism.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Shipments were transported outside of the required refrigerated temperature conditions. Potential hazards if used include nerve damage resulting in paralysis and increased potential for embolism.

Code information

Specific shipments of 2101-0005: Lots A1907006, A1908003; 2101-0010: Lots A1903054, A1906006. UDI 00808232000962, 00808232000979

Distribution pattern

US distribution to California Colorado Florida Georgia Illinois Indiana Kansas Michigan Ohio Pennsylvania Texas Utah Virginia Washington Wisconsin