FDA Medical Device Recalls (openFDA)
Biomet Microfixation, LLC: 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.
- Recall number
- Z-1323-2012
- Recalling firm
- Biomet Microfixation, LLC
- 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.
- Status
- Terminated
- Initiated
- 2011-11-15
- Posted
- 2012-03-27
- Terminated
- 2014-08-04
- Reason
- 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
- 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
- 42
- Distribution
- Worldwide Distribution - USA (nationwide) including the state of Texas and the country of Japan.
- Lot, serial or model codes
- Lot #861200
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- IRQ
- Firm FEI
- 1032347
- Firm city
- Jacksonville
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28