Health & Personal Care
HIGH
FDA DEVICE
Theken Companies Recalls 409 iNSitu Bipolar Hip System Heads for Sterile Barrier Risk (2025)
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.
Theken Companies
Downstream recall