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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94871

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

Open FDA event record

Event summary

Timeline bucket
June 19, 2024
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

3 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 3

UNITRAX Endoprosthesis Head Component - 43mm. Implantable component used in partial hip arthroplasty. Catalog Number: 6942-5-043

Z-2370-2024
Recall number
Z-2370-2024
Initiated
June 19, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Howmedica Osteonics Corp.
Quantity
18 units

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 · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Mislabeled: the size on the package label of the UNITRAX¿ Endoprosthesis Head Component potentially may not match the device within the packaging. This product mix only involves the three (3) sizes (43mm, 42mm, and the 38mm)

Code information

GTIN: 07613327032376 Lot Numbers: 5Y1350, LN815R, PV0H60

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Australia, Hong Kong, and UK.

device · product 2 of 3

UNITRAX Endoprosthesis Head Component - 42mm. Implantable component used in partial hip arthroplasty. Catalog Number: 6942-5-042

Z-2371-2024
Recall number
Z-2371-2024
Initiated
June 19, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Howmedica Osteonics Corp.
Quantity
18 units

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 · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Mislabeled: the size on the package label of the UNITRAX¿ Endoprosthesis Head Component potentially may not match the device within the packaging. This product mix only involves the three (3) sizes (43mm, 42mm, and the 38mm)

Code information

GTIN: 07613327032369 Lot Numbers: 4615EX, HE645D, 8A399N

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Australia, Hong Kong, and UK.

device · product 3 of 3

UNITRAX Endoprosthesis Head Component - 38mm. Implantable component used in partial hip arthroplasty. Catalog Number: 6942-5-038

Z-2372-2024
Recall number
Z-2372-2024
Initiated
June 19, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Howmedica Osteonics Corp.
Quantity
12 units

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 · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Mislabeled: the size on the package label of the UNITRAX¿ Endoprosthesis Head Component potentially may not match the device within the packaging. This product mix only involves the three (3) sizes (43mm, 42mm, and the 38mm)

Code information

GTIN: 07613327032338 Lot Numbers: JT38AD, E94VEV

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Australia, Hong Kong, and UK.