Theken Companies recalled 409 Bipolar Hip Implants on September 11, 2025. The devices failed transit testing and may have compromised sterile barriers. Patients and healthcare providers must stop using the implants immediately.
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
The recall includes Bipolar Head Assemblies in sizes ranging from 38mm to 60mm. The affected models include part IDs 10-22-0038 through 10-22-0060. The implants were distributed nationwide in New Jersey, Pennsylvania, and Texas.
The implants may have potential issues with their sterile barrier due to failed transit testing. This can lead to serious infections or complications if the device is used.
No specific incidents or injuries have been reported to date. The recall is classified as Class II, indicating a high risk but no reported deaths.
Stop using the recalled implants immediately. Follow instructions provided by Theken Companies LLC or your healthcare provider. Contact them for further details regarding the recall.
For more information, contact Theken Companies LLC at the provided contact information on their website. Visit the FDA link for further details on the recall.
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