Class 1 Recall: Greatbatch Medical Recalls Standard Offset Cup Impactor Used for Hip Joint Replacement due to Inadequate Sterilization
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Standard Offset Cup Impactor with POM-C Handle
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; T17703
Distribution Dates: July 30, 2004 to December 22, 2015
Manufacturing Dates: January 2004 to December 2013
Devices Recalled in the U.S.: 2906
The Standard Offset Cup Impactors are reusable handheld devices used during hip joint replacement surgeries to implant cups in the hip socket (acetabulum). The device is provided as non-sterile and must be sterilized prior to use in surgery.
During hip replacement surgery, the ball (femoral head) is removed and replaced with a prosthetic ball, and the acetabulum is removed and replaced with a prosthetic cup.
Reason for Recall
Greatbatch Medical is recalling the Standard Offset Cup Impactor with a POM-C handle that failed sterility testing when sterilized in a dedicated instrument case. Non-sterile surgical devices can lead to infections, and other serious adverse health consequences, including death.
Who May be Affected
Health care providers using this device during hip replacement surgeries
All patient groups undergoing hip replacement procedures involving the Standard Offset Cup Impactor
What to Do
Greatbatch has developed new sterilization recommendations that meet acceptable sterility assurance levels. The device must be individually wrapped during sterilization processing.
On July 29, 2016, Greatbatch Medical informed its customers via letter to follow the updated sterilization instructions.
Customers with questions may contact Greatbatch via telephone at 1-619-498-9487 between the hours of 8:00 am (CT) and 5:00 pm (CT). Customers may also contact the company via email at FieldActionCenter@greatbatch.com.
Date Recall Initiated:
July 29, 2016
The FDA alerts provided by MedWrench are intended to be helpful reminders, but are not to displace the timely alerts provided by the manufacturers of the products or the FDA directly. You should always consult those services prior to making any final decisions as to the timeliness and accuracy of the FDA alerts we distribute. For more visit www.fda.gov.