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

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 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 génération des textes
MIMP3100CHA04     T9109     Impactor / M10
MIMP3100CHA04     T9196     Par la génération 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.

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