Theken recalls specific iNSitu Bipolar Hip System components due to potential sterile barrier issues from failed transit testing. Affected parts include sizes 38mm to 60mm with certain lot numbers.
Downstream recall for RES 97605, BioPro femoral components. Product failed transit testing. Impacted product may have potential issues with sterile barrier.
Theken is recalling specific sizes of bipolar hip implants (38mm to 60mm) because they may have issues with the sterile barrier during transit. This could lead to infection risks if the implants are used without proper sterility.
The recalled implants failed transit testing and may have compromised sterile barriers. This could potentially lead to infection if the implants are used without proper sterility during surgery.
Patients who received the recalled hip implants from Theken Companies LLC are most at risk. The recall affects specific sizes and lot numbers of the bipolar head assemblies.
Check the product's part number (10-22-0038 to 10-22-0060) and lot numbers (2036, 2037, etc.) on the implant packaging. The recall includes specific sizes from 38mm to 60mm.
Review the part number and lot numbers on the implant packaging to confirm if it is in the recalled list.
The recalled implants failed transit testing and may have potential issues with the sterile barrier, which could lead to infection risks if used without proper sterility.
The recall includes bipolar head assemblies for sizes 38mm to 60mm with specific lot numbers (e.g., 2036, 2037, 3495, etc.).
If you have the recalled product, check the part number and lot numbers to confirm. The recall does not specify a remedy, so contact Theken directly for further instructions.
We’ve drafted a message you can send Theken to request your refund or repair — edit it as you like.
Subject: Recall Z-0227-2026 — Theken Theken Hello, I own a Theken that is covered by recall Z-0227-2026 from Theken. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
