Greatbatch Medical Issues Voluntary Field Corrective Action for Standard Offset Cup Impactor

FRISCO, Texas, Nov. 16, 2016 -- On July 29, 2016, Greatbatch Medical initiated a global, voluntary field corrective action for Standard Offset Cup Impactors with POM-C Handle grip that failed sterility testing when housed in a dedicated instrument case using the IFU recommended sterilization procedures. The dedicated instrument case is not manufactured by Greatbatch Medical.

An internal review determined that the sterilization recommendations in the Instructions for Use for the product, which were developed for individually wrapped devices, did not meet requirements for sterility assurance level when sterilized in an instrument case. This situation has the potential to result in surgical infection. Devices may be successfully sterilized according to the IFU recommendations when individually wrapped. No incidents have been reported during clinical use of the product, nor have there been any reported adverse events.

Greatbatch Medical has notified its distributors and customers via overnight mail that Standard Offset Cup Impactor with POM-C Handle grip should be individually wrapped during sterilization processing.

The Company has informed the FDA of this action. The FDA has classified this action as a class 1.

A class 1 recall is defined as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This recall impacts Standard Offset Cup Impactor with POM-C Handle grips manufactured and distributed from 2004 – 2015 as follows:

Name of Product:  Standard Offset Cup Impactor
Quantity:  4478

Greatbatch Medical distributed Standard Offset Cup Impactor with POM-C Handle grips to customers in the following countries: Australia, Austria, Belgium, France, Germany, Greece, Ireland, Italy, Japan, Luxembourg, Netherlands, Norway, South Korea, Spain, Sweden, Switzerland, Taiwan, the United Kingdom, and the United States.

Customers with questions may contact the Company 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 [email protected].

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report online: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form www.fda.gov/medwatch/getforms.htm 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

About Greatbatch Medical
Greatbatch Medical is part of the Integer Holdings Corporation (NYSE:ITGR) family of brands. Greatbatch Medical is committed to the design and manufacture of critical technologies used in medical devices for the cardiology, neurology, vascular and orthopaedic markets. To learn more about Greatbatch Medical, please visit www.greatbatchmedical.com. 

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