Recall Z-0367-2017 ยท HWA Impactor
Greatbatch Medical
Greatbatch, Offset Cup Impactor with the following Parts and Catalogue #: Tl0600 ~ MMP3100CHA04 T10491 MIMP3100CHA04 T12230 M2M1P3100CHA04 T15752 ~MMP3100CHA04 T15949 ~MMP3100CHA04 T17238 MMP3100CHA04 T9954 MMP3100CHA04 T9955 MMP3100CHA04 T8468 MMP3100CHA04 T11506 MMP3100CHA13 T10281 MMP3100CHA04 T8044 ~MMP3100CHA04 T17203 87-4 20-00980 T8177 ~ MMP3100CHA04 T16934 MMP3100CH
| Date | Nov 29, 2016 (initiated Aug 2, 2016) |
| Status | Terminated |
| Reason | On December 17, 2015, Greatbatch discovered that the Standard Offset Cup Impactor with a POM-C handle grip failed sterility testing when housed in a dedicated instrument case using the sterilization parameters identified in the Standard Offset Cup Impactors Instructions for Use (IFU). |
| Root cause | Under Investigation by firm |
| Action | Greatbatch sent an Urgent Medical Device letter dated August 2, 2016, via FedEx to all affected consignees. The letter described the Reason for Field Correction Action, Risk to Health, and Instructions to Customers. Advised consignees to" immediately inform those responsible for sterilization of the devices to utilize the updated sterilization instructions, and post the attached notice where it is clearly visible to personnel who perform sterilization activities". Also instructed consignees to notify their customers and to complete and return the Field Correction Action Response Form. For |
| Quantity | 4478 (2906 US, 1572 OUS) |
| Distribution | Worldwide Distribution - US including CA, IN, KS,NJ, NC, TN, TX, and UT and Internationally to ITALY, JAPAN, FRANCE, SPAIN, GERMANY, NETHERLANDS, GREECE, LUXEMBOURG, SOUTH KOREA, IRELAND, UNITED KINGDOM, AUSTRALIA, AUSTRIA, BELGIUM, SWITZERLAND, NORWAY, SWEDEN, and TAIWAN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.