Class II U.S. Food and Drug Administration

Total Joint Orthopedics, Inc. Brand Name: Klassic BiPolar Head Model/ recall: Potential packaging issue that could compromise the sterile barrier. Defect

Recall published 12 months ago

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.

The hazard: Sterility or particulate concern

Particulate matter or a sterility failure prompted this notice, the most common reason injectable and ophthalmic products are withdrawn.

What the notice says: 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.

Why it matters: The product was made or packaged in conditions that cannot assure sterility, or visible particles were found in it. For anything injected, infused or used in the eye, that is a direct route for contamination into the body.

Symptoms and when to call a doctor

Watch for fever, chills, pain, redness, swelling or discharge at an injection site, and for a red, painful or suddenly blurred eye after using an eye product. Any of these needs same-day medical attention. Do not wait to see whether it settles, and tell the clinician which product and lot you used so it can be reported against the recall.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
Z-0432-2026
Published
November 12, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Total Joint Orthopedics, Inc.
Product type
Medical devices
Units affected
103 units
Distribution
Nationwide
Made in
United States
Lot / code info
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
UPC codes
00814703011931, 00814703011948, 00814703011955, 00814703011962, 00814703011979, 00814703011986, 00814703011993, 00814703012006, 00814703012013, 00814703012020, 00814703012037, 00814703012044, 00814703012051, 00814703012068, 00814703012075, 00814703012082, 00814703012105, 00814703012129

Products covered by this recall

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

Check your product

The notice names 22 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00814703011931
  • 00814703011948
  • 00814703011955
  • 00814703011962
  • 00814703011979
  • 00814703011986
  • 00814703011993
  • 00814703012006
  • 00814703012013
  • 00814703012020
  • 00814703012037
  • 00814703012044
  • 00814703012051
  • 00814703012068
  • 00814703012075
  • 00814703012082
  • 00814703012105
  • 00814703012129

Model or item number

On the rating label, the box or the instruction sheet.

  • 3205.41.022 Klassic BiPolar Head
  • 41 mm OD
  • 22 mm H
  • UDI

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Sterility

Total Joint Orthopedics, Inc. — Particulate matter or a sterility failure prompted this notice, the most common reason injectable and ophthalmic products are withdrawn.

  1. Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.
  2. Call your prescriber or pharmacy today about a replacement from an unaffected lot — do not simply skip doses of a medicine you depend on.
  3. If you are a clinic or pharmacy, quarantine the stock and work it through your usual recall log.
  4. Report any infection or reaction you think the product caused to FDA MedWatch.

What the company owes you

A recalled medicine is the manufacturer’s cost to carry, not yours or your pharmacist’s.

  • The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.
  • Ask the pharmacy to handle the claim where they can — they process recall returns in bulk and it saves you the correspondence.
  • Keep the carton, the leaflet and the pharmacy label together until the claim is closed.
  • Costs beyond the price of the medicine need to go to the company directly, in writing, with the recall number quoted.

Company contact: Total Joint Orthopedics, Inc. — 1567 E Stratford Ave, Salt Lake City, UT, 84106-3559

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Total Joint Orthopedics, Inc. medical devices 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. 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.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00814703011931, 00814703011948, 00814703011955; model number 3205.41.022 Klassic BiPolar Head, 41 mm OD, 22 mm H. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.

Can I get my money back?

The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.

Where was the recalled product sold?

It was distributed nationwide.

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