Device recall
Z-0946-2017: Modular Necks: The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems are…
FDA device recall · Class II · Smith & Nephew, Inc.
Key facts
| Recall number (Z-number) | Z-0946-2017 |
|---|---|
| Recall event | 75873 |
| Product | Modular Necks: The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or non-inflammatory degenerative joint disease (NIDJD) or any… |
| Product code | MEH |
| Recalling firm | Smith & Nephew, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 19, 2019 |
| 510(k) numbers | K072417, K080625 |
| FEI number | 1020279 |
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