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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97708

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

Open FDA event record

Event summary

Timeline bucket
September 23, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Total Joint Orthopedics, Inc.

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

Brand Name: Klassic BiPolar Head Model/Catalog Number: 3205.41.022 Klassic BiPolar Head, 41 mm OD, 22 mm Head; 3205.42.022 Klassic BiPolar Head, 42 mm OD, 22 mm Head; 3205.43.022 Klassic BiPolar Head, 43 mm OD, 22 mm Head; 3205.44.028 Klassic BiPolar Head, 44 mm OD, 28 mm Head; 3205.45.028 Klassic BiPolar Head, 45 mm OD, 28 mm Head; 3205.46.028 Klassic BiPolar Head, 46 mm OD, 28 mm Head; 3205.47.028 Klassic BiPolar Head, 47 mm OD, 28 mm Head; 3205.48.028 Klassic BiPolar Head, 48 mm OD, 28 mm Head; 3205.49.028 Klassic BiPolar Head, 49 mm OD, 28 mm Head; 3205.50.028 Klassic BiPolar Head, 50 mm OD, 28 mm Head; 3205.51.028 Klassic BiPolar Head, 51 mm OD, 28 mm Head; 3205.52.028 Klassic BiPolar Head, 52 mm OD, 28 mm Head; 3205.53.028 Klassic BiPolar Head, 53 mm OD, 28 mm Head; 3205.54.028 Klassic BiPolar Head, 54 mm OD, 28 mm Head; 3205.55.028 Klassic BiPolar Head, 55 mm OD, 28 mm Head; 3205.56.028 Klassic BiPolar Head, 56 mm OD, 28 mm Head; 3205.58.028 Klassic BiPolar Head, 58 mm OD, 28 mm Head; 3205.60.028 Klassic BiPolar Head, 60 mm OD, 28 mm Head

Z-0432-2026
Recall number
Z-0432-2026
Initiated
September 23, 2025
Classification
Class II
Status
Ongoing
Quantity
103 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
packaging issue
Sterility assurance reason.sterility_assurance · v1.0.0
loss of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.

Code information

Part Number/UDI/Lot Number: 3205.41.022 00814703011931 3205.42.022 00814703011948 3205.43.022 00814703011955 3205.44.028 00814703011962 3205.45.028 00814703011979 3205.46.028 00814703011986 3205.47.028 00814703011993 3205.48.028 00814703012006 3205.49.028 00814703012013 3205.50.028 00814703012020 3205.51.028 00814703012037 3205.52.028 00814703012044 3205.53.028 00814703012051 3205.54.028 00814703012068 3205.55.028 00814703012075 3205.56.028 00814703012082 3205.58.028 00814703012105 3205.60.028 00814703012129

Distribution pattern

US Nationwide distribution in the states of Ohio, Texas, Florida, Georgia, and North Carolina.

Field note

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