Exact FDA event identifier

Event 84346

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

Open FDA event record

Event summary

Timeline bucket: November 07, 2019
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Howmedica Osteonics Corp.

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 Omnifit Crossfire 10 Degree Series II Insert- intended for cementless and/or cemented fixation within the prepared acetabulum Catalog #: 2041C-3254

Z-0811-2020

Recall number: Z-0811-2020
Initiated: November 07, 2019
Classification: Class II
Status: Terminated
Recalling firm: Howmedica Osteonics Corp.
Quantity: 20 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

May have a missing locking wire causing delay in surgery while retrieving a back-up device or implantation of a device that is missing a locking wire

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

May have a missing locking wire causing delay in surgery while retrieving a back-up device or implantation of a device that is missing a locking wire

Code information

Lot Number: 53778501 UDIs: (01)04546540035806(17)201108(10)53778501

Distribution pattern

CA, FL, GA , IA, MA, MI, NC, OH, WI Foreign: Canada, Japan