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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84458

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

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Event summary

Timeline bucket
December 05, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Stryker GmbH

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 T2 Alpha Delta Strike Plate IMN Instruments - part of the IMN Instruments System and is used to support insertion and withdrawal of nails through the Targeting Device Catalog Number: 2351-0050

Z-0780-2020
Recall number
Z-0780-2020
Initiated
December 05, 2019
Classification
Class II
Status
Terminated
Recalling firm
Stryker GmbH
Quantity
433 (289 units U.S. / 144 units OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Instrument can break at the level of the thread when being exposed to high forces during nail implantation or removal which can lead to complications during nail insertion and removal.

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

Instrument can break at the level of the thread when being exposed to high forces during nail implantation or removal which can lead to complications during nail insertion and removal.

Code information

All lots UDI: (01)07613327350210

Distribution pattern

Worldwide distribution - US Nationwide distribution and countries of Switzerland, France, Spain, United Kingdom, Italy, Sweden, Netherlands, Australia.