Device recall
Z-1677-2010: 17 mm Mallory Head Calcar 55 mm repl. femoral/100% porous 18.5 mm minimum ream…
FDA device recall · Class II · Biomet, Inc.
Key facts
| Recall number (Z-number) | Z-1677-2010 |
|---|---|
| Recall event | 55365 |
| Product | 17 mm Mallory Head Calcar 55 mm repl. femoral/100% porous 18.5 mm minimum ream dia. x 220 mm rt., Sterile, REF CP154593, Biomet Orthopaedics, Warsaw, IN. Implant device intended for use in femoral revision surgery. |
| Product code | LPH |
| Recalling firm | Biomet, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 18, 2010 |
| 510(k) numbers | K031693 |
| FEI number | 1825034 |
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