The U.S. Food and Drug Administration has issued a Class 1 recall for a handheld instrument used during hip-replacement surgery. The device failed sterility tests.

Greatbatch Medical Recalls The Affected Instrument

Greatbatch Medical recalled the instrument, a Standard Offset Cup Impactor. The instrument enables doctors to implant cups and balls in the joint area after the removal of their orthopedic counterparts – the acetabulum and the femoral head. The directions on how to decontaminate the instrument in its accompanying case were inadequate.

“Non-sterile surgical devices can lead to infections, and other serious adverse health consequences, including death,” the FDA states on its Web site, noting the company has since updated the sterilization process to meet federal standards.

Greatbatch Medical, in July of 2016, initiated corrective action on the recalled instrument. They determined the device must be individually wrapped for sterilization to be successful. The company says no adverse events have been reported.

“Greatbatch Medical has notified its distributors and customers via overnight mail that Standard Offset Cup Impactor with POM-C Handle grip should be individually wrapped during sterilization processing,” according to a corporate press release.

Urgent Field Safety Notice Contact Information

The instruments in question were made between 2004 and 2013 and distributed through 2015. Consumers can call (619) 498-9487 or email fieldactioncenter@greatbatch.com with any questions or concerns.

“Torque limiting devices are supplied non-sterile and require cleaning and steam sterilization prior to use and subsequent re-use,” states an Urgent Field Safety Notice released by Greatbatch Medical. “This issue carries with it the possibility of patient infection. We deeply regret this inconvenience, but we greatly appreciate your understanding as we take actions to ensure patient and customer satisfaction.”