Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
Mentor Texas
Class I - Dangerous
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
Class I - Dangerous
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
Class I - Dangerous
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
Due to a manufacturing issue, Implant may have a potentially weakened area on the base patch portion of the implant which may cause leakage/deflation of the affected device.
Class I - Dangerous
Missing Dome Pack accessory.
The CPX4 Tissue Expander may have been packaged in the Artoura Tissue Expander box.
The CPX4 Tissue Expander may have been packaged in the Artoura Tissue Expander box.
Tissue expander product mix found: CPX4 350cc was placed in a carton for the CPX4 450cc
Tissue expander product mix found: CPX4 350cc was placed in a carton for the CPX4 450cc
Class I - Dangerous
The box of 300cc MemoryGel Breast Implant was labeled with null manufacturing and expiration dates.
Class I - Dangerous
The IFU provided in the affected units of the MENTOR MemoryGel Resterilizable Sizer is incorrect. Those units include the IFU for the MENTOR MemoryShape Resterilizable Sizer.
The device labeling is stamped with 330cc and the device is actually 380cc device.