Z-2070-2017 Class II Terminated
FDA device recall Z-2070-2017 was initiated by Mentor Texas, LP. on March 27, 2017 and is designated Class II. Reason for recall: Missing Dome Pack accessory. The recall status is terminated (terminated June 13, 2017). Affected quantity: 28 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 17, 2017
- Initiation Date
- March 27, 2017
- Termination Date
- June 13, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 28 units
Product Description
Mentor Smooth Round SPECTRUM Post- Operatively Adjustable Saline Breast Implant, Product Code: 350-1490, UDI/GTIN: 00081317002048
Reason for Recall
Missing Dome Pack accessory.
Distribution Pattern
US Distribution to the states of : MI, CA, CT, IL, IN, NY, NC, OH and OK.
Code Information
Lot Number: 7377332