Exact FDA event identifier

Event 92257

2 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: April 13, 2023
Product types: Device
Classifications: Class II
Statuses: Ongoing
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

2 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 2

TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM-Intended for knee replacement Catalog Number: 5531-G-312-E

Z-1653-2023

Recall number: Z-1653-2023
Initiated: April 13, 2023
Classification: Class II
Status: Ongoing
Recalling firm: Howmedica Osteonics Corp.
Quantity: 24 units in total

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

Mislabeled

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

Mislabeled:Labeled Catalog Number: 5531-G-312-E, TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM, may contain Catalog Number: 5532-G-413-E, TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM, and vice versa

Code information

GTIN: 07613327390698 Lot Number: JH3AHJ

Distribution pattern

US Nationwide - Worldwide Distribution: CT, FL, IN, KY, MT, NJ, OR, PA, SC Foreign: China, Japan

device · product 2 of 2

TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM Intended for knee replacement Catalog Number: 5532-G-413-E

Z-1654-2023

Recall number: Z-1654-2023
Initiated: April 13, 2023
Classification: Class II
Status: Ongoing
Recalling firm: Howmedica Osteonics Corp.
Quantity: 24 units in total