Recall Z-1323-2012 ยท IRQ Unit, Heating, Powered
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 LO
| Date | Mar 27, 2012 (initiated Nov 15, 2011) |
| Status | Terminated |
| 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 noti |
| Quantity | 42 |
| Distribution | Worldwide Distribution - USA (nationwide) including the state of Texas and the country of Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.