Hip Replacement Surgical Device Recalled Due Amid Sterilization Concerns

A recall has been issued for about 3,000 medical devices found in operating rooms nationwide, which are commonly used during hip replacement surgery, but may not be sterile, posing a risk of severe and life-threatening infections. 

The FDA announced a Standard Offset Cup Impactor recall on December 16, indicating that the devices may not have been adequately sterilized. The hip implant surgical tools are provided as non-sterile, and must be sterilized before use during surgery. However, the action was taken after it was determined that the devices failed sterility testing after being sterilized in a dedicated instrument case.

The recall has categorized as Class I by the FDA, meaning that continued use of the device carries a risk of severe injury or death. However, there have been no reports of hip infections linked to these devices.

The Standard Offset Cup Impactors are handheld medical devices used in hip joint replacement surgeries. They are used to implant cups into the hip socket.

Even if a hospital attempts to sterilize the hip surgery device according to the provided instructions, patients may be exposed to a risk of infection.

The recall affects 2,906 Greatbatch Medical Standard offset Cup Impactors with POM-C Handles, with model numbers T6318; T7821; T8042; T8043; T8044; T8088; T8143; T8177; T8184; T8333; T8468; T8487; T9196; T9316; T9348; T9360; T9747; T9894; T9954; T9955; T10243; T10281; T10287;T10600; T10491; T10753; T10861; T11209; T11340; T11506; T12230; T12699; T12861; T13344; T13480; T13642; T13722; T14384; T15311; T15752; T15949; T16427; T16611; T16661; T16934; T17203; T17238; T17321; T17650; and T17703. They were distributed from July 30, 2004, to December 22, 2015, and manufactured from January 2004 through December 2013. The devices were distributed worldwide.

The FDA indicates that Greatbatch has developed new sterilization procedure recommendations, which include individually wrapping the tools during sterilization processing. The company has sent out letters with the updated instructions to its customers.

Customers with questions can contact Greatbatch medical by calling 1-619-498-9487, or by sending an email to FieldActionCenter@greatbatch.com.

Adverse events or reactions should be reported to the FDA’s MedWatch adverse event reporting program.