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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80613

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

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Event summary

Timeline bucket
June 27, 2018
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 ANKLE ARTHRODESIS NAIL RIGHT 10MMX200MM Item Number: 1819-1020S T2 ANKLE ARTHRODESIS NAIL RIGHT 12MMX200MM 1819-1220S T2 LONG PROXIMAL HUMERAL NAIL LEFT 240mm1832-2824S T2 LONG PROXIMAL HUMERAL NAIL LEFT 280mm 1832-2828S T2 LONG PROXIMAL HUMERAL NAIL RIGHT 260mm 1832-3826S T2 Ankle Arthrd Nail lft 1818-1115S

Z-2884-2018
Recall number
Z-2884-2018
Initiated
June 27, 2018
Classification
Class II
Status
Terminated
Recalling firm
Stryker GmbH
Quantity
38

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Incomplete seal
Sterility assurance reason.sterility_assurance · v1.0.0
seal on the Tyvek lid may compromise the sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Incomplete seal on the Tyvek lid may compromise the sterility of the device

Code information

Item Number Lot Number: 1819-1020S K0ACFED; 1819-1220S K0CAEC4; 1832-2824S K0BF6C6; 1832-2828S K0CC742; 1832-3826S K0BF6D2; 1818-1115S K0B906C

Distribution pattern

US distribution to KY