Device recall
Z-0823-2012: The 45mm Left Standard Offset Mandible is one component in the Total…
FDA device recall · Class II · Biomet Microfixation, Inc.
Key facts
| Recall number (Z-number) | Z-0823-2012 |
|---|---|
| Recall event | 60910 |
| Product | The 45mm Left Standard Offset Mandible is one component in the Total Temporomandibular Joint (TMJ) Replacement System used to functionally reconstruct a diseased and/or damaged temporomandibular joint. The component is labeled in part: "REF: 24-6646***TMJ SYSTEM LEFT STANDARD OFFSET MANDIBULAR… |
| Product code | MPL |
| Recalling firm | Biomet Microfixation, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 6, 2012 |
| PMA numbers | P020016 |
| 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