Greatbatch Medical, Offset Cup Impactor - Inadequate Sterilization
Recall Class: Class I
Date Recall Initiated: January 31, 2014
Product: Offset Cup Impactor
The affected device was manufactured from January 2004 through January 2013 and distributed from January 2004 through December 2013.
Use: The Offset Cup Impactor is a reusable instrument used during acetabular replacement surgery to implant an acetabular cup. The Standard Offset Cup Impactor is provided non-sterile and must be sterilized prior to use in surgery. The Standard Offset Cup Impactor is used to implant cups during many minimally invasive surgical approaches to Total Hip Arthroplasty.
2300 Berkshire Lane North
Plymouth, MN 55441
Reason for Recall:
Greatbatch Medical has initiated a global Field Corrective Action for the Standard Offset Cup Impactor since the product was first released in 2004.
The firm identified through internal Sterility Assurance Level validation testing that a sterility assurance level of 10-6 is not achieved on the Standard Offset Cup Impactor when it is subjected to the steam sterilization cycles and associated dry times that are specified in the current Instructions for Use (IFU) provided with the device.
The Standard Offset Cup Impactor is provided non-sterile and must be sterilized prior to use in a surgery. This recalled product may cause serious adverse health consequences, including death.
Public Contact: For questions about this recall, customers may contact their local Greatbatch Medical Representative at 1-763-951-8235 or email them at FieldActionCenter@Greatbatch.com.
FDA District: Minneapolis District Office
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.