Z-1323-2012

The LactoSorb Heat/Contouring Pen is a disposable alkaline-battery powered device. Product is labeled in...

Name: Z-1323-2012 The LactoSorb Heat/Contouring Pen is a disposable alkaline-battery powered device. Product is labeled in...
Creator: Biomet Microfixation, LLC
Published: 2011-11-15
License: https://open.fda.gov/license/

Biomet Microfixation / initiated 2011-11-15 / Terminated / root cause: labeling and UDI

FDA source

Biomet Microfixation, LLC began a recall of The LactoSorb Heat/Contouring Pen is a disposable alkaline-battery powered device. Product is labeled in part: "***REF 915-3100 LOT***LACTOSORB* SYSTEM... on 2011-11-15. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1323-2012
Status: Terminated
Initiated: 2011-11-15
Posted: 2012-03-27
Terminated: 2014-08-04
Recalling firm: Biomet Microfixation
Product: The LactoSorb Heat/Contouring Pen is a disposable alkaline-battery powered device. Product is labeled in part: "***REF 915-3100 LOT***LACTOSORB* SYSTEM HEAT/CONTOURING PEN AND TIPS***QTY 00001***STERILE R STERILE EO***PVC, BRASS***WARNING: DO NOT USE IN THE PRESENCE OF FLAMMABLE MATERIALS. FIRE COULD RESULT.***BIOMET MICROFIXATION 1520 TRADEPORT DRIVE, JACKSONVILLE, FL 32218 USA***#915-3100 LOT***QTY 00001, HEAT/CONTOURING PEN AND TIPS***PVC, BRASS***". Product Usage: Two tips are provided with the body of the device to cut / contour the edges of the LactoSorb plates by heating the material.
Product code: IRQ Unit, Heating, Powered
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
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: 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.
Quantity in commerce: 42
Distribution: Worldwide Distribution - USA (nationwide) including the state of Texas and the country of Japan.
Product codes and lots: Lot #861200

Product code IRQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)