Device recall event
Recall event 87549: BIOTRONIK Inc
FDA device recall · Class II · Terminated
Key facts
| Recall event number | 87549 |
|---|---|
| Recalling firm | BIOTRONIK Inc |
| Recall class | Class II |
| Status | Terminated |
| PMA numbers | P050023, P050023S058, P050023S076, P050023S079, P050023S085, P050023S087, P050023S103, P980023, P980023S093 |
At a glance
- 10–99 Recalled products (Z-numbers)
- None Linked 510(k)s
- 1–9 Recall events for this firm
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recall events
A recall event groups every recalled product (Z-number) from one recall action by a firm. Class I recalls involve a reasonable probability of serious harm; Class III recalls are unlikely to cause harm.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database