Device recall
Z-0416-2014: SIGMA LCS HIGH PERFORMANCE" MBT KEEL PUNCH NONCEMENTED Size 2-3 HP M.B.T. Keel…
FDA device recall · Class II · DePuy Orthopaedics, Inc.
Key facts
| Recall number (Z-number) | Z-0416-2014 |
|---|---|
| Recall event | 66864 |
| Product | SIGMA LCS HIGH PERFORMANCE" MBT KEEL PUNCH NONCEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty. |
| Product code | JWH |
| Recalling firm | DePuy Orthopaedics, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 24, 2015 |
| 510(k) numbers | K032151, K033272 |
| FEI number | 1818910 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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