Device recall
Z-1755-2015: Comprehensive Shoulder System, 4 mm, 122 mm long, Primary Shoulder Stem…
FDA device recall · Class III · Biomet, Inc.
Key facts
| Recall number (Z-number) | Z-1755-2015 |
|---|---|
| Recall event | 71171 |
| Product | Comprehensive Shoulder System, 4 mm, 122 mm long, Primary Shoulder Stem, Ti-6Al-4V, Standard Length Porous Plasma. Shoulder joint replacement components include humeral stems, humeral heads, and glenoid components. |
| Product code | MBF |
| Recalling firm | Biomet, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | May 16, 2016 |
| 510(k) numbers | K060692 |
| FEI number | 1825034 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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