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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93051

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

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Event summary

Timeline bucket
September 15, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Tornier, Inc

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 Tornier Perform Reversed Augmented Glenoid Lateralized Baseplate, 25mm, Offset +3mm, REF DWJ502

Z-0113-2024
Recall number
Z-0113-2024
Initiated
September 15, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Tornier, Inc
Quantity
30 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
One lot of Tournier Perform Reversed Lateralized Baseplates were found to have been manufactured with 6mm spacers instead of 3mm spacers. This nonconformance prevents the central screw from being able to thread into the baseplate.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

One lot of Tournier Perform Reversed Lateralized Baseplates were found to have been manufactured with 6mm spacers instead of 3mm spacers. This nonconformance prevents the central screw from being able to thread into the baseplate.

Code information

UDI/DI 10846832062017, Lot Number 1756123

Distribution pattern

US: CA, CO, IL, MA, MN, NC, OR, RI, SC, TN

Field note

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