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

Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

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 - January 29, 2014 - Frisco, TX - Greatbach, 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 Number Part Number Part Name
MIMP3100320 T12121 Impactor / M8 x 1
MIMP3100ADM01 T16604 Impactor notched connection
MIMP3100CH14 T11340 Impactor / M8 x 1
MIMP3100CHA04 T10281 Impactor / M10 x 1
MIMP3100CHA04 T10287 Impactor / M10
MIMP3100CHA04 T10491 Impactor / M8
MIMP3100CHA04 T10507 Impactor / M8 x 1
MIMP3100CHA04 T10600 Impactor / 3/8 - 32 UNEF
MIMP3100CHA04 T10604 Impactor / M6
MIMP3100CHA04 T10861 Impactor / M8
MIMP3100CHA04 T12230 Impactor / 7/16 - 20 UNF
MIMP3100CHA04 T12288 Impactor / M10 x 1
MIMP3100CHA04 T12305 Impactor JMM Q3
MIMP3100CHA04 T12391 Impactor / M10
MIMP3100CHA04 T12699 Impactor / M10
MIMP3100CHA04 T13344 Impactor / 7/16 - 20 UNF
MIMP3100CHA04 T13722 Impactor / 3/8 - 24 UNF
MIMP3100CHA04 T13999 Impactor / M10
MIMP3100CHA04 T14155 Impactor / M10
MIMP3100CHA04 T15752 Impactor / 3/8 - 24 UNF
MIMP3100CHA04 T15949 Impactor / 3/8 - 24 UNF
MIMP3100CHA04 T16117 Impactor / 3/8 - 24 UNF
MIMP3100CHA04 T16427 Impacteur
MIMP3100CHA04 T16611 Impactor / 5/16 - 24 UNF
MIMP3100CHA04 T16661 Impactor / M10 x 1
MIMP3100CHA04 T16829 Impactor / M8
MIMP3100CHA04 T17062 Impactor / 3/8 - 16 UNC
MIMP3100CHA04 T17203 Impactor / 3/8 - 24 UNF
MIMP3100CHA04 T17238 Impactor / 7/16 - 20 UNF
MIMP3100CHA04 T17321 Impactor / M10
MIMP3100CHA04 T6318 Impactor / 3/8 - 24 UNF
MIMP3100CHA04 T7821 Impactor / M6
MIMP3100CHA04 T8042 Impactor / 3/8 - 16 UNC
MIMP3100CHA04 T8043 Impactor / 5/16 - 24 UNF
MIMP3100CHA04 T8044 Impactor Biomet ES
MIMP3100CHA04 T8087 Impactor / M7 x 1
MIMP3100CHA04 T8088 Impactor / 3/8 - 32 UNEF
MIMP3100CHA04 T8093 Impactor / M8
MIMP3100CHA04 T8095 Impactor / M6
MIMP3100CHA04 T8143 Impactor / 1/4 - 28 UNF
MIMP3100CHA04 T8177 Impactor / 1/4 - 28 UNF
MIMP3100CHA04 T8184 Impactor / 3/8 - 16 UNC
MIMP3100CHA04 T8277 Impactor / M6
MIMP3100CHA04 T8310 Impactor / 3/8 - 24 UNF
MIMP3100CHA04 T8333 Impactor / M8 x 1
MIMP3100CHA04 T8468 Par la gnration des textes
MIMP3100CHA04 T9109 Impactor / M10
MIMP3100CHA04 T9196 Par la gnration des textes
MIMP3100CHA04 T9205 Impactor / M10 x 1
MIMP3100CHA04 T9316 Impactor / M6
MIMP3100CHA04 T9348 Impactor / M10 x 1
MIMP3100CHA04 T9360 Impactor / M8
MIMP3100CHA04 T9556 Impactor / M8
MIMP3100CHA04 T9557 Impactor / 3/8 - 24 UNF
MIMP3100CHA04 T9747 Impactor / M14 x 1.5
MIMP3100CHA04 T9894 Impactor / M10
MIMP3100CHA04 T9954 Impactor / M8
MIMP3100CHA04 T9955 Impactor / 1/4 - 28 UNF
MIMP3100CHA04 T9999 Impactor / M10 x 0.75
MIMP3100CHA041 T12861 Impactor / 5/16 - 24 UNF
MIMP3100CHA042 T13480 Impactor / M10 x 1
MIMP3100CHA05 T8487 Impactor / M8
MIMP3100CHA08 T10243 Impactor / M14 x 1.5
MIMP3100CHA09 T10484 Impactor / 3/8 - 24 UNF
MIMP3100CHA10 T10753 Impactor / M14 x 1.5
MIMP3100CHA10 T13642 Impactor / M14 x 1.5
MIMP3100CHA12 T11209 Impactor / M8
MIMP3100CHA14 T14384 Impacteur
MIMP3100CHA17 T15311 Impacteur
MIMP3100CHA60 T15822 Impactor notched connection
MIMP3100CHA62 T16934 Impactor / 3/8 - 24 UNF
MIMP3100CHAN043 T12767 Impactor 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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