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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94444

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

Open FDA event record

Event summary

Timeline bucket
April 16, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Tornier S.A.S.

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

Stryker Blueprint Software, Catalog #BPUE001.

Z-1883-2024
Recall number
Z-1883-2024
Initiated
April 16, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Tornier S.A.S.
Quantity
Unavailable

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software bug

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The software bug allows for case planning with anatomic glenoid Perform / Perform Augmented implants and anatomic humeral Tornier Flex implant configurations that are incompatible and do not have regulatory approval.

Code information

Versions 2.1.4 to 4.0.2, UDI-DI numbers 03700434023114, 03700434023107, 03700434015065, and 03700434015058.

Distribution pattern

US Nationwide distribution in the states of FL, KY, NJ, and WI.

Field note

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