Device recall
Z-1756-2015: MCK Maximum Congruent Knee System, BIOMET FINNED PRI STEM 40MM; 80 x 10MM; 80 x…
FDA device recall · Class III · Biomet, Inc.
Key facts
| Recall number (Z-number) | Z-1756-2015 |
|---|---|
| Recall event | 71171 |
| Product | MCK Maximum Congruent Knee System, BIOMET FINNED PRI STEM 40MM; 80 x 10MM; 80 x 12.5 MM; 80 x 15 MM Knee joint replacement prostheses components include femoral, tibial, and patellar components. |
| Product code | JWH |
| Recalling firm | Biomet, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | May 16, 2016 |
| 510(k) numbers | K142933, K915132 |
| FEI number | 1825034 |
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