Class II U.S. Food and Drug Administration

Theken Companies LLC iNSitu Bipolar Hip System, Bipolar head implant Part ID recall: Downstream recall for RES 97605, BioPro femoral components. Product failed

Recall published 12 months ago

Downstream recall for RES 97605, BioPro femoral components. Product failed transit testing. Impacted product may have potential issues with sterile barrier.

The hazard: Sterility or particulate concern

The concern here is contamination of a product that bypasses the body’s normal defences, which is why the threshold for recalling it is low.

What the notice says: Downstream recall for RES 97605, BioPro femoral components. Product failed transit testing. Impacted product may have potential issues with sterile barrier.

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-0227-2026
Published
October 29, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Theken Companies LLC
Product type
Medical devices
Units affected
409
Distribution
Nationwide
Made in
United States
Lot / code info
10-22-0038 UDI-DI 00816127029431 Lots 2036, 2036-RP, 3495, 3495-1; 10-22-0040 UDI-DI 00816127029448 Lots 2037, 2037-RP, 3491, 3491-1; 10-22-0042 UDI-DI 00816127029455 Lot 2038-RP; 10-22-0044 UDI-DI 00816127029462 Lots 2039-RP, 3496-1; 10-22-0046 UDI-DI 00816127029479 Lots 2040, 2040-RP, 3492, 3492-1; 10-22-0048 UDI-DI 00816127029486 Lot 2041-RP; 10-22-0050 UDI-DI 00816127029493 Lots 2042, 2042-RP; 10-22-0052 UDI-DI 00816127029509 Lots 2043, 2043-RP; 10-22-0054 UDI-DI 00816127029516 Lots 2044, 2044-RP; 10-22-0056 UDI-DI 00816127029523 Lots 2045, 2045-RP; 10-22-0058 UDI-DI 00816127029530 Lots 2046, 2046-RP, 3493; 10-22-0060 UDI-DI 00816127029547 Lots 2047, 2047-RP, 3494 All lots/serial numbers
UPC codes
00816127029431, 00816127029448, 00816127029455, 00816127029462, 00816127029479, 00816127029486, 00816127029493, 00816127029509, 00816127029516, 00816127029523, 00816127029530, 00816127029547

Products covered by this recall

iNSitu Bipolar Hip System, Bipolar head implant Part ID Description 10-22-0038 Bipolar Head Assembly, Size 38mm 10-22-0040 Bipolar Head Assembly, Size 40mm 10-22-0042 Bipolar Head Assembly, Size 42mm 10-22-0044 Bipolar Head Assembly, Size 44mm 10-22-0046 Bipolar Head Assembly, Size 46mm 10-22-0048 Bipolar Head Assembly, Size 48mm 10-22-0050 Bipolar Head Assembly, Size 50mm 10-22-0052 Bipolar Head Assembly, Size 52mm 10-22-0054 Bipolar Head Assembly, Size 54mm 10-22-0056 Bipolar Head Assembly, Size 56mm 10-22-0058 Bipolar Head Assembly, Size 58mm 10-22-0060 Bipolar Head Assembly, Size 60mm

Check your product

The notice names 33 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.

  • 00816127029431
  • 00816127029448
  • 00816127029455
  • 00816127029462
  • 00816127029479
  • 00816127029486
  • 00816127029493
  • 00816127029509
  • 00816127029516
  • 00816127029523
  • 00816127029530
  • 00816127029547

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 2036
  • 2036-RP
  • 3495
  • 3495-1
  • 2037
  • 2037-RP
  • 3491
  • 3491-1
  • 2038-RP
  • 2039-RP
  • 3496-1
  • 2040
  • 2040-RP
  • 3492
  • 3492-1
  • 2041-RP
  • 2042
  • 2042-RP
  • 2043
  • 2043-RP

Serial number

On the rating plate, often next to the date of manufacture.

  • s — 409

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

Theken Companies LLC — The concern here is contamination of a product that bypasses the body’s normal defences, which is why the threshold for recalling it is low.

  1. Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.
  2. If you are a clinic or pharmacy, quarantine the stock and work it through your usual recall log.
  3. Report any infection or reaction you think the product caused to FDA MedWatch.
  4. Do not use a vial or syringe with visible particles, cloudiness or discolouration, whether or not it is on the recall list.

Getting a replacement supply

Do not let a refund question interrupt your treatment. Deal with the supply first and the money second.

  • Call the pharmacy before you run low. They can see which lot they dispensed to you and will usually swap it the same day.
  • Insurers do not normally count a recall replacement against a refill limit. If one is refused, ask the pharmacist to call it through as a recall override.
  • Over-the-counter products are refunded at the till like any other purchase; the recall notice on your phone is enough to explain the return.
  • If the manufacturer runs a direct reimbursement form, it will be linked from the official notice on this page.

Company contact: Theken Companies LLC — 1800 Triplett Blvd, Akron, OH, 44306-3311

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 Theken Companies LLC medical devices recalled?

Downstream recall for RES 97605, BioPro femoral components. Product failed transit testing. Impacted product may have potential issues with sterile barrier. Downstream recall for RES 97605, BioPro femoral components. Product failed transit testing. Impacted product may have potential issues with sterile barrier.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00816127029431, 00816127029448, 00816127029455; lot code 2036, 2036-RP, 3495. 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?

Call the pharmacy before you run low. They can see which lot they dispensed to you and will usually swap it the same day.

Where was the recalled product sold?

It was distributed nationwide.

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