MERZ AESTHETICS, Radiesse Volume Advantage 1.5 CC, Injectable Implant, Part Number 8071M0H1 and 8071M0K1, Sterile, Rx ON

FDA device recall Z-0145-2012 · posted 2011-11-01 · Terminated

Recall details

Recalling firm

Merz Aesthetics, Inc.

Reason for recall

There is a potential leakage of product that may occur with Merz Aesthetics 1.5cc syringes of Radiesse Dermal Filler. When using the syringe, Health Care Professionals should be alerted to the potential for product that my leak pass the plunger at the proximal end of the syring. The defect may result in infection requiring medical intervention to prevent impairment or damage. To date Merz has n

Action taken

On 8/18/11, consignees were sent a Merz Aesthetics "Urgent Medical Device Recall" letter dated August 15, 2011. The letter was addressed to "Dear Health Care Professional". The letter described the product and the problem and listed the details regarding this issue.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

LMH

Quantity affected

311,582

Distribution

Worldwide distribution including USA, Puerto Rico, Dominican Republic, Hong Kong, Israel, Netherlands, Germany, South Korea, and Canada.

Date initiated

2011-08-18

Date posted

2011-11-01

Date terminated

2012-05-01

Location

Franksville, WI