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

FRISCO, Texas, Nov. 16, 2016 (GLOBE NEWSWIRE) -- 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.
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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
Catalog Number Part Number Part Name
MIMP3100CHA04 T10600 Impacteur / 3/8 - 32 UNEF
MIMP3100CHA04 T10491 Offset Cup Impactor
MIMP3100CHA04 T12230 Impacteur / 7/16 - 20 UNF
MIMP3100CHA04 T15752 Impacteur / 3/8 - 24 UNF
MIMP3100CHA04 T15949 Impacteur / 3/8 - 24 UNF
MIMP3100CHA04 T17238 Impacteur / 7/16 - 20 UNF
MIMP3100CHA04 T9954 Impacteur / M8
MIMP3100CHA04 T9955 Impacteur / 1/4 - 28 UNF
MIMP3100CHA04 T8468 Offset Cup Impactor
MIMP3100CHA13 T11506 Impacteur / M9 x 1
MIMP3100CHA04 T10281 Impacteur / M10 x 1
MIMP3100CHA04 T8044 Impacteur Biomet ES
87-420-00980 T17203 Offset Cup Impactor
MIMP3100CHA04 T8177 Impacteur / 1/4 - 28 UNF
MIMP3100CHA62 T16934 Impacteur / 3/8 - 24 UNF
SHP9109.00010 T11340 Impacteur / M8 x 1
MIMP3100CHA04 T8043 Impacteur / 5/16 - 24 UNF
MIMP3100CHA04 T17321 Impacteur / M10
GG920010029 T15311 Impacteur
255000110 T17650 Offset Cup Impactor
803-11-103 T8143 Impacteur / 1/4 - 28 UNF
EK-00200690 T14384 Impacteur
XEB227242 T16661 Impacteur / M10 x 1
MIMP3100CHA04 T9316 Impacteur / M6
500325 T13642 Impacteur / M14 x 1.5
MIMP3100CHA10 T10753 Impacteur / M14 x 1.5
MIMP3100CHA04 T9348 Impacteur / M10 x 1
MIMP3100CHA042 T13480 Impacteur / M10 x 1
MIMP3100CHA08 T10243 Impacteur / M14 x 1.5
MIMP3100CHA12 T11209 Impacteur / M8
MIMP3100CHA04 T10861 Impacteur / M8
MIMP3100CHA04 T16427 Impacteur
MIMP3100CHA04 T9894 Impacteur / M10
MIMP3100CHA041 T12861 Impacteur / 5/16 - 24 UNF
2002CUPI T8088 Offset Cup Impactor
T16611 T16611 Impacteur / 5/16 - 24 UNF
MIMP3100CHA04 T9360 Impacteur / M8
MIMP3100CHA04 T13344 Impacteur / 7/16 - 20 UNF
MIMP3100CHA04 T13722 Impacteur / 3/8 - 24 UNF
MIMP3100CHA04 T7821 Impacteur / M6
MIMP3100CHA04 T10287 Impacteur / M10
MIMP3100CHA04 T8042 Impacteur / 3/8 - 16 UNC
SC3561 T17703 Offset Cup Impactor
MIMP3100CHA04 T6318 Impacteur / 3/8 - 24 UNF
MIMP3100CHA04 T8333 Impacteur / M8 x 1
MIMP3100CHA04 T9747 Impacteur / M14 x 1.5
MIMP3100CHA05 T8487 Impacteur / M8
MIMP3100CHA04 T8184 Impacteur / 3/8 - 16 UNC
MIMP3100CHA04 T9196 Par la génération des textes
MIMP3100CHA04 T12699 Impacteur / M10

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.

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