FRISCO, Texas -- (Business Wire)
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 Impactorsmanufactured and distributed from
2004 to 2013 as follows:
Name of Product:Standard Offset Cup Impactor Quantity:4889 |
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Catalog Number
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Part Number
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Part Name
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MIMP3100320
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T12121
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Impactor / M8 x 1
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MIMP3100ADM01
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T16604
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Impactor notched connection
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MIMP3100CH14
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T11340
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Impactor / M8 x 1
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MIMP3100CHA04
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T10281
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Impactor / M10 x 1
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MIMP3100CHA04
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T10287
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Impactor / M10
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MIMP3100CHA04
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T10491
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Impactor / M8
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MIMP3100CHA04
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T10507
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Impactor / M8 x 1
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MIMP3100CHA04
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T10600
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Impactor / 3/8 - 32 UNEF
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MIMP3100CHA04
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T10604
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Impactor / M6
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MIMP3100CHA04
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T10861
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Impactor / M8
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MIMP3100CHA04
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T12230
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Impactor / 7/16 - 20 UNF
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MIMP3100CHA04
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T12288
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Impactor / M10 x 1
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MIMP3100CHA04
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T12305
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Impactor JMM Q3
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MIMP3100CHA04
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T12391
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Impactor / M10
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MIMP3100CHA04
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T12699
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Impactor / M10
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MIMP3100CHA04
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T13344
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Impactor / 7/16 - 20 UNF
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MIMP3100CHA04
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T13722
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Impactor / 3/8 - 24 UNF
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MIMP3100CHA04
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T13999
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Impactor / M10
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MIMP3100CHA04
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T14155
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Impactor / M10
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MIMP3100CHA04
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T15752
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Impactor / 3/8 - 24 UNF
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MIMP3100CHA04
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T15949
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Impactor / 3/8 - 24 UNF
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MIMP3100CHA04
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T16117
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Impactor / 3/8 - 24 UNF
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MIMP3100CHA04
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T16427
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Impacteur
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MIMP3100CHA04
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T16611
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Impactor / 5/16 - 24 UNF
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MIMP3100CHA04
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T16661
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Impactor / M10 x 1
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MIMP3100CHA04
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T16829
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Impactor / M8
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MIMP3100CHA04
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T17062
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Impactor / 3/8 - 16 UNC
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MIMP3100CHA04
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T17203
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Impactor / 3/8 - 24 UNF
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MIMP3100CHA04
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T17238
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Impactor / 7/16 - 20 UNF
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MIMP3100CHA04
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T17321
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Impactor / M10
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MIMP3100CHA04
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T6318
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Impactor / 3/8 - 24 UNF
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MIMP3100CHA04
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T7821
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Impactor / M6
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MIMP3100CHA04
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T8042
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Impactor / 3/8 - 16 UNC
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MIMP3100CHA04
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T8043
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Impactor / 5/16 - 24 UNF
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MIMP3100CHA04
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T8044
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Impactor Biomet ES
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MIMP3100CHA04
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T8087
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Impactor / M7 x 1
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MIMP3100CHA04
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T8088
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Impactor / 3/8 - 32 UNEF
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MIMP3100CHA04
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T8093
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Impactor / M8
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MIMP3100CHA04
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T8095
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Impactor / M6
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MIMP3100CHA04
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T8143
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Impactor / 1/4 - 28 UNF
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MIMP3100CHA04
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T8177
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Impactor / 1/4 - 28 UNF
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MIMP3100CHA04
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T8184
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Impactor / 3/8 - 16 UNC
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MIMP3100CHA04
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T8277
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Impactor / M6
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MIMP3100CHA04
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T8310
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Impactor / 3/8 - 24 UNF
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MIMP3100CHA04
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T8333
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Impactor / M8 x 1
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MIMP3100CHA04
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T8468
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Par la génération des textes
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MIMP3100CHA04
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T9109
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Impactor / M10
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MIMP3100CHA04
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T9196
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Par la génération des textes
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MIMP3100CHA04
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T9205
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Impactor / M10 x 1
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MIMP3100CHA04
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T9316
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Impactor / M6
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MIMP3100CHA04
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T9348
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Impactor / M10 x 1
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MIMP3100CHA04
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T9360
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Impactor / M8
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MIMP3100CHA04
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T9556
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Impactor / M8
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MIMP3100CHA04
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T9557
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Impactor / 3/8 - 24 UNF
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MIMP3100CHA04
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T9747
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Impactor / M14 x 1.5
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MIMP3100CHA04
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T9894
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Impactor / M10
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MIMP3100CHA04
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T9954
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Impactor / M8
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MIMP3100CHA04
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T9955
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Impactor / 1/4 - 28 UNF
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MIMP3100CHA04
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T9999
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Impactor / M10 x 0.75
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MIMP3100CHA041
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T12861
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Impactor / 5/16 - 24 UNF
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MIMP3100CHA042
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T13480
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Impactor / M10 x 1
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MIMP3100CHA05
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T8487
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Impactor / M8
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MIMP3100CHA08
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T10243
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Impactor / M14 x 1.5
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MIMP3100CHA09
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T10484
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Impactor / 3/8 - 24 UNF
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MIMP3100CHA10
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T10753
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Impactor / M14 x 1.5
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MIMP3100CHA10
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T13642
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Impactor / M14 x 1.5
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MIMP3100CHA12
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T11209
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Impactor / M8
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MIMP3100CHA14
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T14384
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Impacteur
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MIMP3100CHA17
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T15311
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Impacteur
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MIMP3100CHA60
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T15822
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Impactor notched connection
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MIMP3100CHA62
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T16934
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Impactor / 3/8 - 24 UNF
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MIMP3100CHAN043
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T12767
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Impactor JMM Q3
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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 at763-951-8235.
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.
Contacts:
Greatbatch, Inc.
Investor Relations:
Elizabeth
Cowell, 214-618-4982
ecowell@greatbatch.com
or
Media:
Christopher
Knospe, 716-759-5727
cknospe@greatbatch.com
Source: Greatbatch, Inc.
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