FDA MedWatch - Standard Offset Cup Impactor with POM-C Handle by Greatbatch Medical: Class I Recall - Inadequate Sterilization

["FDA MedWatch" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: FDA MedWatch - Standard Offset Cup Impactor with POM-C Handle by Greatbatch Medical: Class I Recall - Inadequate Sterilization

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Standard Offset Cup Impactor with POM-C Handle by Greatbatch Medical: Class I Recall - Inadequate Sterilization

AUDIENCE: Risk Manager, Orthopedics

ISSUE: 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.

Distribution Dates: July 30, 2004 to December 22, 2015
Manufacturing Dates: January 2004 to December 2013
Devices Recalled in the U.S.: 2906

See the Recall Notice for a listing of affected model numbers.

BACKGROUND: 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.

RECOMMENDATION: 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@xxxxxxxxxxxxxx.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the FDA recall notice, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm533967.htm

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