Theken Companies recalled 409 iNSitu Bipolar Hip System bipolar head implants distributed nationwide in New Jersey, Pennsylvania and Texas. The devices failed transit testing and may have a compromised sterile barrier. Hospitals and surgeons should stop using the device and follow recall instructions.
Downstream recall for RES 97605, BioPro femoral components. Product failed transit testing. Impacted product may have potential issues with sterile barrier.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Theken Companies LLC or your healthcare provider for instructions. Notification method: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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The iNSitu Bipolar Hip System is used in hip replacement procedures. The bipolar head assembly is a component that articulates with the acetabular cup during joint replacement.
A transit testing failure raises concerns about the sterile barrier integrity. If the barrier is breached, there is a risk of infection or implant-associated complications.
This recall is not indicated as part of a broader industry pattern.
Hospitals and patients may experience delays in device availability and require medical team coordination to replace affected components. No injuries have been reported yet.
UDI-DI numbers and lot codes are printed on device packaging and labeling. Model numbers are on the device itself or accompanying documentation.
Recall processing and notices are expected to continue in the coming weeks. Recipients should follow the manufacturer’s instructions and coordinate in
Document all recall communications, inventory recalls, and any patient-level actions taken. Retain photos, letters, and receipts related to the recall.
Quantity: 409 units Distribution: US nationwide in NJ, PA, TX Recall date: 2025-09-11 Model numbers: 10-22-0038, 10-22-0040, 10-22-0042, 10-22-0044, 10-22-0046, 10-22-0048, 10-22-0050, 10-22-0052 UDIs: 00816127029431; 00816127029448; 00816127029455; 00816127029462; 00816127029479; 00816127029486; 00816127029493; 00816127029509 Lots: 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 Price: Not disclosed Sold since: Unknown Manufacturer: Theken Companies LLC Country of origin: Unknown
No injuries or incidents have been reported.
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