Greatbatch, Inc. Issues Voluntary Field Corrective Action for Standard Offset Cup Impactor
Date of Recall
2014-03-11Recall Details
- 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 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 |
Recall Comments
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