Recall Z-0702-2020 ยท MRD Mammary Sizer
Allergan PLC
NATRELLE Resterilizable Sizers for the styles and sizes: Style 15, Style 20, Inspira X (responsive gel), Inspira F (responsive gel), Inspira LP (responsive gel), Inspira M (responsive gel), Inspira L (responsive gel), Inspira ST L (Soft Touch gel), Inspira ST LP (Soft Touch Gel), Inspira ST M (Soft Touch Gel), Inspira ST F (Soft Touch Gel), Inspira ST X (Soft Touch Gel) Style 10/UDI: NATRELLE Sty
| Date | Nov 6, 2019 |
| Status | Terminated |
| Reason | The firm has became aware that 2D barcodes on breast implants and sizers may be unreadable by GS-1 configured scanners. These 2D barcodes contain a group separators between fixed-length element string in the UDI data chain of the 2D barcode, which is not formatted to the GS1 standard. |
| Root cause | Error in labeling |
| Action | Allergan sent out the field notification to consignees via email on 11/06/19. For consignees whom email was unavailable, a field notification letter was sent via overnight mail with tracking to all consignees.In addition to informing them about the correction, the notification requested consignees do the following: 1. You may continue to use these products. If your facility uses GS-1 configured scanners and the 2D barcode cannot be scanned, the UDI information can be entered manually by using the human readable information that appears next to the 2D barcode.: 1. To enter the UDI, For the |
| Distribution | US:AL, AR,AZ,CA,CO,DC,FL,GA,HI,IA,ID,IL,IN,KS,KY,LA,MA,MD,ME,MI,MN,MO,MS,MT,NC,ND,NE,NH,NJ,NM,NV,NY,OH,OK,OR,PA,PR,RI,SC,SD,TN,TX,UT,VA,WA,WI,WY |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K831566 | CUI MAMMARY PROTHESIS SIZER Cox-Uphuff Intl., Aug 12, 1983 |