Device recall
Z-1676-2013: Bigliani/Flatow The Complete Shoulder Solution, Humeral Stem Provisional 12mm x…
FDA device recall · Class II · Zimmer, Inc.
Key facts
| Recall number (Z-number) | Z-1676-2013 |
|---|---|
| Recall event | 65290 |
| Product | Bigliani/Flatow The Complete Shoulder Solution, Humeral Stem Provisional 12mm x 170mm This reusable trial device is used in orthopaedic joint replacement and is specific to the replaced joint (e.g. hip, knee, shoulder, ankle, elbow). It can be made of metal or plastic. |
| Product code | HSD |
| Recalling firm | Zimmer, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 30, 2014 |
| 510(k) numbers | K110791 |
| FEI number | 1000220733 |
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