Device recall
Z-0537-2010: Otto Bock Modular Knee Joint, 3R66, Otto Bock HealthCare GmbH, Max-Nader-StraBe…
FDA device recall · Class II · Bock,Otto,Orthopedic Ind,Inc
Key facts
| Recall number (Z-number) | Z-0537-2010 |
|---|---|
| Recall event | 50486 |
| Product | Otto Bock Modular Knee Joint, 3R66, Otto Bock HealthCare GmbH, Max-Nader-StraBe 15 . 37115 Duderstadt /Germany. Pediatric Prosthetic Device used by Lower Limb amputees. |
| Product code | ISY |
| Recalling firm | Bock,Otto,Orthopedic Ind,Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 10, 2011 |
| FEI number | 2182293 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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