Exact FDA event identifier

Event 87684

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, 2021
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Stryker Leibinger GmbH & Co. KG

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

DirectInject consists of a sterile dual paste system which is calcium phosphate based. Upon injection through the Mixer-Cannula, the two pastes form a cement paste which is moldable. The injected cement paste will harden under normal body conditions to form hydroxyapatite.

Z-1436-2021

Recall number: Z-1436-2021
Initiated: April 01, 2021
Classification: Class II
Status: Terminated
Recalling firm: Stryker Leibinger GmbH & Co. KG
Quantity: 321 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Inability for the user to inject the paste from the syringe into the target location.

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

Inability for the user to inject the paste from the syringe into the target location.

Code information

Lot: DI20311,DI20307 Product Code (UDI): 07613327123265

Distribution pattern

Worldwide distribution - US Nationwide distribution and the countries of Germany, Italy, France, Australia, Japan.