Device recall
Z-1323-2012: The LactoSorb Heat/Contouring Pen is a disposable alkaline-battery powered…
FDA device recall · Class II · Biomet Microfixation, LLC
Key facts
| Recall number (Z-number) | Z-1323-2012 |
|---|---|
| Recall event | 61271 |
| 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… |
| Product code | IRQ |
| Recalling firm | Biomet Microfixation, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 4, 2014 |
| FEI number | 1032347 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database