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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 89520

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

Open FDA event record

Event summary

Timeline bucket
December 30, 2021
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

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

Exeter V40 Cemented Hip (125mm) Stem, Part Number 0580-1-044

Z-0651-2022
Recall number
Z-0651-2022
Initiated
December 30, 2021
Classification
Class II
Status
Terminated
Recalling firm
Howmedica Osteonics Corp.
Quantity
59 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential label mix between certain lots of Exeter V40 Cemented Hip (125mm) Stem and Exeter V40 Cemented Hip (150mm) Stem.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential label mix between certain lots of Exeter V40 Cemented Hip (125mm) Stem and Exeter V40 Cemented Hip (150mm) Stem.

Code information

GTIN: 04546540509048; Lot G7900236

Distribution pattern

The product was distributed to the following US states: MI

device · product 2 of 2

Exeter V40 Cemented Hip (150mm) Stem, Part Number 0580-1-440

Z-0652-2022
Recall number
Z-0652-2022
Initiated
December 30, 2021
Classification
Class II
Status
Terminated
Recalling firm
Howmedica Osteonics Corp.
Quantity
58 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential label mix between certain lots of Exeter V40 Cemented Hip (125mm) Stem and Exeter V40 Cemented Hip (150mm) Stem.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential label mix between certain lots of Exeter V40 Cemented Hip (125mm) Stem and Exeter V40 Cemented Hip (150mm) Stem.

Code information

GTIN: 04546540153296; Lot G7900352

Distribution pattern

The product was distributed to the following US states: MI