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.
###
Legal Disclaimer:
EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.
