UPDATED 03/14/2014. FDA classified recall as Class I.
AUDIENCE: Risk Manager, Surgery
ISSUE: Greatbatch, Inc. initiated a voluntary field corrective action for all Standard Offset Cup Impactors after an internal review determined that the sterilization recommendation in the Instructions for Use for the product did not meet requirements for sterility assurance, which has the potential to result in surgical infection. No incidents have been reported during clinical use of the product, nor have there been any reported adverse events.
Greatbatch has developed new sterilization recommendations that meet acceptable sterility assurance levels (AAMI ST79 standard) and provided them to affected customers.
This action impacts all Standard Offset Cup Impactors manufactured and distributed from 2004 to 2013. See the Press Release for a listing of affected products and part numbers.
BACKGROUND: Greatbatch Inc. distributed Standard Offset Cup Impactors to customers in the following countries: Australia, Austria, Belgium, China, France, Germany, Greece, Ireland, Italy, Japan, Luxembourg, Netherlands, Norway, South Korea, Spain, Sweden, Switzerland, Taiwan, the United Kingdom, and the United States.
RECOMMENDATION: Customers who have this product should immediately begin utilizing the new sterilization instructions. Customers with questions may contact the company via telephone at 763-951-8235. Customers may also contact the company via e-mail at FieldActionCenter@greatbatch.com
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.htm
- 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