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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 72054

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

Open FDA event record

Event summary

Timeline bucket
August 20, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Orthovita, Inc., dBA Stryker Orthobiologics.

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

Aliquot Delivery Kit (Syringe and Plunger); for use in open and percutaneous procedures to facilitate placement of bone cement in weakened or diminished bone

Z-2772-2015
Recall number
Z-2772-2015
Initiated
August 20, 2015
Classification
Class II
Status
Terminated
Quantity
9805

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Two isolated instances of holes in the outer header bag component of the double barrier sterile packaging configuration

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Two isolated instances of holes in the outer header bag component of the double barrier sterile packaging configuration

Code information

All lots, Model Number of device: 2090-0501, 2090-0502, 2090-0504, 2090-0505

Distribution pattern

Worldwide Distribution - Nationwide Distribution and to the countries of : Australia, Belgium, Denmark, France, Germany, Italy, Malta, Netherlands, South Africa, Spain, Sweden, Switzerland, Turkey and United Kingdom.