Radiesse, Injectable Implant - 1.3cc Syringe, Sterile, Sterilized Using Steam, Use Before 2013-01, Ref 8046M7, Lot 10244

FDA device recall Z-2221-2011 · posted 2011-05-19 · Terminated

Recall details

Recalling firm

Merz Aesthetics, Inc.

Reason for recall

Merz Aesthetics, Inc. is recalling 1 lot (1034417) of Radiesse 1.3 cc Implant. The lot was supposed to be scrapped because it had failed to meet its Loss On Drying (LOD) specification. Unfortunately it had been marked as approved, released and shipped.

Action taken

The firm, Merz Aesthetics, Inc., contacted its consignee/customer via e-mail on April 6, 2011. The e-mail states the product, problem and action to be taken. The customer was instructed to follow up with the concerned and inform the status time to time to the Recall Coordinator. The product was confirmed to be quarantined and has been requested to be sent back. If you need any additional information regarding this issue or if you have any questions, contact the International Regulatory Affairs Specialist at 262-835-3300 ext. 3081.

Root cause

Employee error

Status

Terminated

Product code

LMH

Quantity affected

695 units

Distribution

International only: Taiwan.

Date initiated

2011-04-06

Date posted

2011-05-19

Date terminated

2011-11-17

Location

Franksville, WI