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Greatbatch, Inc. Issues Voluntary Field Corrective Action for Standard Offset Cup Impactor

 

Contact
Consumer:
763-951-8235

Media:
Christopher Knospe
716-759-5727
cknospe@greatbatch.com
 

FOR IMMEDIATE RELEASE - March 11, 2014 - Frisco, TX - On January 29, 2014, 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. Customers who have this product should immediately begin utilizing the new sterilization instructions.

The company has informed the FDA of this action, which impacts all Standard Offset Cup Impactors manufactured and distributed from 2004 to 2013 as follows:

Name of Product: Standard Offset Cup Impactor
Quantity: 4889

Catalog NumberPart NumberPart Name
MIMP3100320T12121Impactor / M8 x 1
MIMP3100ADM01T16604Impactor notched connection
MIMP3100CH14T11340Impactor / M8 x 1
MIMP3100CHA04T10281Impactor / M10 x 1
MIMP3100CHA04T10287Impactor / M10
MIMP3100CHA04T10491Impactor / M8
MIMP3100CHA04T10507Impactor / M8 x 1
MIMP3100CHA04T10600Impactor / 3/8 - 32 UNEF
MIMP3100CHA04T10604Impactor / M6
MIMP3100CHA04T10861Impactor / M8
MIMP3100CHA04T12230Impactor / 7/16 - 20 UNF
MIMP3100CHA04T12288Impactor / M10 x 1
MIMP3100CHA04T12305Impactor JMM Q3
MIMP3100CHA04T12391Impactor / M10
MIMP3100CHA04T12699Impactor / M10
MIMP3100CHA04T13344Impactor / 7/16 - 20 UNF
MIMP3100CHA04T13722Impactor / 3/8 - 24 UNF
MIMP3100CHA04T13999Impactor / M10
MIMP3100CHA04T14155Impactor / M10
MIMP3100CHA04T15752Impactor / 3/8 - 24 UNF
MIMP3100CHA04T15949Impactor / 3/8 - 24 UNF
MIMP3100CHA04T16117Impactor / 3/8 - 24 UNF
MIMP3100CHA04T16427Impacteur
MIMP3100CHA04T16611Impactor / 5/16 - 24 UNF
MIMP3100CHA04T16661Impactor / M10 x 1
MIMP3100CHA04T16829Impactor / M8
MIMP3100CHA04T17062Impactor / 3/8 - 16 UNC
MIMP3100CHA04T17203Impactor / 3/8 - 24 UNF
MIMP3100CHA04T17238Impactor / 7/16 - 20 UNF
MIMP3100CHA04T17321Impactor / M10
MIMP3100CHA04T6318Impactor / 3/8 - 24 UNF
MIMP3100CHA04T7821Impactor / M6
MIMP3100CHA04T8042Impactor / 3/8 - 16 UNC
MIMP3100CHA04T8043Impactor / 5/16 - 24 UNF
MIMP3100CHA04T8044Impactor Biomet ES
MIMP3100CHA04T8087Impactor / M7 x 1
MIMP3100CHA04T8088Impactor / 3/8 - 32 UNEF
MIMP3100CHA04T8093Impactor / M8
MIMP3100CHA04T8095Impactor / M6
MIMP3100CHA04T8143Impactor / 1/4 - 28 UNF
MIMP3100CHA04T8177Impactor / 1/4 - 28 UNF
MIMP3100CHA04T8184Impactor / 3/8 - 16 UNC
MIMP3100CHA04T8277Impactor / M6
MIMP3100CHA04T8310Impactor / 3/8 - 24 UNF
MIMP3100CHA04T8333Impactor / M8 x 1
MIMP3100CHA04T8468Par la génération des textes
MIMP3100CHA04T9109Impactor / M10
MIMP3100CHA04T9196Par la génération des textes
MIMP3100CHA04T9205Impactor / M10 x 1
MIMP3100CHA04T9316Impactor / M6
MIMP3100CHA04T9348Impactor / M10 x 1
MIMP3100CHA04T9360Impactor / M8
MIMP3100CHA04T9556Impactor / M8
MIMP3100CHA04T9557Impactor / 3/8 - 24 UNF
MIMP3100CHA04T9747Impactor / M14 x 1.5
MIMP3100CHA04T9894Impactor / M10
MIMP3100CHA04T9954Impactor / M8
MIMP3100CHA04T9955Impactor / 1/4 - 28 UNF
MIMP3100CHA04T9999Impactor / M10 x 0.75
MIMP3100CHA041T12861Impactor / 5/16 - 24 UNF
MIMP3100CHA042T13480Impactor / M10 x 1
MIMP3100CHA05T8487Impactor / M8
MIMP3100CHA08T10243Impactor / M14 x 1.5
MIMP3100CHA09T10484Impactor / 3/8 - 24 UNF
MIMP3100CHA10T10753Impactor / M14 x 1.5
MIMP3100CHA10T13642Impactor / M14 x 1.5
MIMP3100CHA12T11209Impactor / M8
MIMP3100CHA14T14384Impacteur
MIMP3100CHA17T15311Impacteur
MIMP3100CHA60T15822Impactor notched connection
MIMP3100CHA62T16934Impactor / 3/8 - 24 UNF
MIMP3100CHAN043T12767Impactor JMM Q3

 

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.

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 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.

About Greatbatch, Inc.
Greatbatch, Inc. (NYSE: GB) provides top-quality technologies to industries that depend on reliable, long-lasting performance. The company develops and manufactures critical medical device technologies for the cardiac, neuromodulation, vascular and orthopaedic markets; and batteries for high-end niche applications in the portable medical, energy, military, and other markets. Additional information is available at www.greatbatch.com.

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