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

November 16 2016

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 NumberPart NumberPart Name
MIMP3100CHA04T10600Impacteur / 3/8 - 32 UNEF
MIMP3100CHA04T10491Offset Cup Impactor
MIMP3100CHA04T12230Impacteur / 7/16 - 20 UNF
MIMP3100CHA04T15752Impacteur / 3/8 - 24 UNF
MIMP3100CHA04T15949Impacteur / 3/8 - 24 UNF
MIMP3100CHA04T17238Impacteur / 7/16 - 20 UNF
MIMP3100CHA04T9954Impacteur / M8
MIMP3100CHA04T9955Impacteur / 1/4 - 28 UNF
MIMP3100CHA04T8468Offset Cup Impactor
MIMP3100CHA13T11506Impacteur / M9 x 1
MIMP3100CHA04T10281Impacteur / M10 x 1
MIMP3100CHA04T8044Impacteur Biomet ES
87-420-00980T17203Offset Cup Impactor
MIMP3100CHA04T8177Impacteur / 1/4 - 28 UNF
MIMP3100CHA62T16934Impacteur / 3/8 - 24 UNF
SHP9109.00010T11340Impacteur / M8 x 1
MIMP3100CHA04T8043Impacteur / 5/16 - 24 UNF
MIMP3100CHA04T17321Impacteur / M10
GG920010029T15311Impacteur
255000110T17650Offset Cup Impactor
803-11-103T8143Impacteur / 1/4 - 28 UNF
EK-00200690T14384Impacteur
XEB227242T16661Impacteur / M10 x 1
MIMP3100CHA04T9316Impacteur / M6
500325T13642Impacteur / M14 x 1.5
MIMP3100CHA10T10753Impacteur / M14 x 1.5
MIMP3100CHA04T9348Impacteur / M10 x 1
MIMP3100CHA042T13480Impacteur / M10 x 1
MIMP3100CHA08T10243Impacteur / M14 x 1.5
MIMP3100CHA12T11209Impacteur / M8
MIMP3100CHA04T10861Impacteur / M8
MIMP3100CHA04T16427Impacteur
MIMP3100CHA04T9894Impacteur / M10
MIMP3100CHA041T12861Impacteur / 5/16 - 24 UNF
2002CUPIT8088Offset Cup Impactor
T16611T16611Impacteur / 5/16 - 24 UNF
MIMP3100CHA04T9360Impacteur / M8
MIMP3100CHA04T13344Impacteur / 7/16 - 20 UNF
MIMP3100CHA04T13722Impacteur / 3/8 - 24 UNF
MIMP3100CHA04T7821Impacteur / M6
MIMP3100CHA04T10287Impacteur / M10
MIMP3100CHA04T8042Impacteur / 3/8 - 16 UNC
SC3561T17703Offset Cup Impactor
MIMP3100CHA04T6318Impacteur / 3/8 - 24 UNF
MIMP3100CHA04T8333Impacteur / M8 x 1
MIMP3100CHA04T9747Impacteur / M14 x 1.5
MIMP3100CHA05T8487Impacteur / M8
MIMP3100CHA04T8184Impacteur / 3/8 - 16 UNC
MIMP3100CHA04T9196Par la génération des textes
MIMP3100CHA04T12699Impacteur / 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.

Customers with questions may contact the Company via telephone at 1-619-498-9487 between the hours of 8:00 am (CT) and 5:00 pm (CT). Customers may also contact the company via email 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 Medical
Greatbatch Medical is part of the Integer Holdings Corporation (NYSE:ITGR) family of brands. Greatbatch Medical is committed to the design and manufacture of critical technologies used in medical devices for the cardiology, neurology, vascular and orthopaedic markets. To learn more about Greatbatch Medical, please visit www.greatbatchmedical.com

 

Investor Relations:
Amy Wakeham
IR@greatbatch.com
214.618.4978

Media Relations:
Kelly Butler
kbutler@greatbatch.com
214.618.4216

Source: Integer Holdings Corporation