Brand Name: Klassic BiPolar Head recallZ-0432-2026 · Total Joint Orthopedics, Inc. · initiated Sep 23, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Total Joint Orthopedics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Packaging
What the company is doing
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.
Recall details
- Recall number
- Z-0432-2026
- Status
- Open, Classified
- Initiated by the company
- Sep 23, 2025
- Posted by the FDA
- Nov 5, 2025
- Recalling firm
- Total Joint Orthopedics, Inc.
- Quantity
- 103 units
- Product code
- KWY
- FDA submissions
- K143113
- Distribution
- US Nationwide distribution in the states of Ohio, Texas, Florida, Georgia, and North Carolina.
Product description
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
Code information (models, lots, serial numbers)
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
Devices named in this recall
18 devices in the FDA device registry whose identifier appears in the recall's code information.
- Klassic BiPolar Head, 41 mm OD, 22 mm Head 3205.41.022Total Joint Orthopedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall0 reports
- Klassic BiPolar Head, 42 mm OD, 22 mm Head 3205.42.022Total Joint Orthopedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall0 reports
- Klassic BiPolar Head, 43 mm OD, 22 mm Head 3205.43.022Total Joint Orthopedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall0 reports
- Klassic BiPolar Head, 44 mm OD, 28 mm Head 3205.44.028Total Joint Orthopedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall0 reports
- Klassic BiPolar Head, 45 mm OD, 28 mm Head 3205.45.028Total Joint Orthopedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall0 reports
- Klassic BiPolar Head, 46 mm OD, 28 mm Head 3205.46.028Total Joint Orthopedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall0 reports
- Klassic BiPolar Head, 47 mm OD, 28 mm Head 3205.47.028Total Joint Orthopedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall0 reports
- Klassic BiPolar Head, 48 mm OD, 28 mm Head 3205.48.028Total Joint Orthopedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall0 reports
- Klassic BiPolar Head, 49 mm OD, 28 mm Head 3205.49.028Total Joint Orthopedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall0 reports
- Klassic BiPolar Head, 50 mm OD, 28 mm Head 3205.50.028Total Joint Orthopedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall0 reports
- Klassic BiPolar Head, 51 mm OD, 28 mm Head 3205.51.028Total Joint Orthopedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall0 reports
- Klassic BiPolar Head, 52 mm OD, 28 mm Head 3205.52.028Total Joint Orthopedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall0 reports
- Klassic BiPolar Head, 53 mm OD, 28 mm Head 3205.53.028Total Joint Orthopedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall0 reports
- Klassic BiPolar Head, 54 mm OD, 28 mm Head 3205.54.028Total Joint Orthopedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall0 reports
- Klassic BiPolar Head, 55 mm OD, 28 mm Head 3205.55.028Total Joint Orthopedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall0 reports
- Klassic BiPolar Head, 56 mm OD, 28 mm Head 3205.56.028Total Joint Orthopedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall0 reports
- Klassic BiPolar Head, 58 mm OD, 28 mm Head 3205.58.028Total Joint Orthopedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall0 reports
- Klassic BiPolar Head, 60 mm OD, 28 mm Head 3205.60.028Total Joint Orthopedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall0 reports
Other devices under the same FDA submission
1 device cleared under K143113 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- 28mm Femoral Head, 12/14 taper, +3.5mm offset 3200.28.350Total Joint Orthopedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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