Z-0432-2026Class II

Brand Name: Klassic BiPolar Head Model/Catalog Number: 3205.41.022 Klassic BiPolar Head, 41 mm OD, 22 mm...

Name: Z-0432-2026 Brand Name: Klassic BiPolar Head Model/Catalog Number: 3205.41.022 Klassic BiPolar Head, 41 mm OD, 22 mm...
Creator: Total Joint Orthopedics, Inc.
Published: 2025-09-23
License: https://open.fda.gov/license/

Total Joint Orthopedics, Inc. / initiated 2025-09-23 / Open, Classified / root cause: packaging

FDA source

Total Joint Orthopedics, Inc. began a recall of 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... on 2025-09-23. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0432-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-09-23
Posted: 2025-11-05
Recalling firm: Total Joint Orthopedics, Inc.
Product: 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
Product code: KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
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.
Root cause tag: packaging
FDA root cause: Packaging
Action: On September 5, 2025 Total Joint issued customer a Field action notification. On September 23, 2025, Total Joint issued a Urgent Medical Device Recall Notification. Total Joint ask consignees to take the following actions: 1. Stop implanting the affected product. 2. Locate and quarantine all affected inventory. 3. With preliminary info we initially sent a Market Withdrawal notification on 9/05/2025 to initiate the quarantining and return of all BiPolar Heads in your possession. 4. A list of all BiPolar Heads in your possession as of 9/05/2025 is shown within the letter, if you have already returned them we appreciate your swift response, if not please return these items immediately. 5. Please complete and return the attached acknowledgment form confirming receipt of this notice and detailing the quantities returned. If inventory discrepancies are identified, please note that in the Return Response Box. 6. Please contact Total Joint Orthopedics at (801)486-6070 with any questions or concerns.
Quantity in commerce: 103 units
Distribution: US Nationwide distribution in the states of Ohio, Texas, Florida, Georgia, and North Carolina.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0432-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0432-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-11-12	2025-11-05

Product code KWY

K143113Class IIKlassic BiPolar SystemTotal Joint Orthopedics / cleared 2015-01-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)