Sulzer Orthopedics Recalls Hip Joints

The recall was initiated after the company discovered unacceptable level of residue of a mineral oil-based lubricant on the surface of its Inter-Op shells. Sulzer determined that this residue might prevent the implant from properly bonding with the bone, causing the shell to loosen.

As of this date, 129 cases of loosening have been documented, all of which had presented symptoms of aseptic loosening within the first six months after implantation.
Around 17,500 patients have received the Inter-Op shells, and close to 90% were implanted in the United States. Sulzer's surgical advisors do not recommend that patients undergo removal of the Inter-Op unless they exhibit symptoms of loosening.

In the meantime, Sulzer has introduced a series of rigorous cleaning procedures in the manufacturing process that the company believes have solved the cause of the recall.
"We accept full responsibility for the recall,” said Andre P. Buchel, CEO of Sulzer Medica. "We will treat all patients fairly and apologize for any effect the recall may have on patients and their families.”



Related Links:
Sulzer Medica