The LactoSorb Heat/Contouring Pen is a disposable alkaline-battery powered device. Product is labeled in part: "***REF 9

FDA device recall Z-1323-2012 · posted 2012-03-27 · Terminated

Recall details

Recalling firm

Biomet Microfixation, LLC

Reason for recall

On 11/15/2011 Biomet Microfixation, Jacksonville, FL initiated a recall of their Acticort Heat/Contouring Pen, Model #915-3100, Lot #861200. Product is incorrectly labeled

Action taken

Biomet Microfixation, LLC sent an Urgent Medical Device Safety Alert letter dated November 15, 2011 via E-mail, letter or telephone call to all consignees affected. The letter identified the affected product, problem and actions to be taken. Each consignee was Instructioned to take the following actions: 1) If you have any unopened boxes of the product in question, please place this notice with it; 2) Please fill out the attached Inventory Reconciliation sheet and FAX to the attention of the Global Complaint Coordinator; and 3) If you have further distributed this product , you must notify the recipient of this action by providing the recipient a copy of this notice. This letter must be given to the personnel responsible for receiving field action notices. For questions please contact Christy Cain at 1-800-874-7711 or 904-741-4400, extension 468, Monday through Friday, 8am-4pm ET.

Root cause

Error in labeling

Status

Terminated

Product code

IRQ

Quantity affected

42

Distribution

Worldwide Distribution - USA (nationwide) including the state of Texas and the country of Japan.

Date initiated

2011-11-15

Date posted

2012-03-27

Date terminated

2014-08-04

Location

Jacksonville, FL