Device recall
Z-0821-2017: Tibial Component Metal Cased Small Long; Tibial Component Metal Cased Small…
FDA device recall · Class II · Stanmore Implants Worldwide Ltd.
Key facts
| Recall number (Z-number) | Z-0821-2017 |
|---|---|
| Recall event | 75892 |
| Product | Tibial Component Metal Cased Small Long; Tibial Component Metal Cased Small Short; Tibial Component Metal Cased Std Long; Tibial Component Metal Cased Std Short The product is a component is a systems that is intended for the replacement if diseased or deficient bone around the knee joint, distal… |
| Product code | KRO |
| Recalling firm | Stanmore Implants Worldwide Ltd. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 17, 2017 |
| 510(k) numbers | K120992 |
| FEI number | 3004105610 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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