Device recall
Z-1092-2014: 00434811113, REF I4348-111-13 Zimmer Trabecular Metal Shoulder Humeral Stem 48…
FDA device recall · Class II · Zimmer, Inc.
Key facts
| Recall number (Z-number) | Z-1092-2014 |
|---|---|
| Recall event | 67067 |
| Product | 00434811113, REF I4348-111-13 Zimmer Trabecular Metal Shoulder Humeral Stem 48 Degrees 11 mm Stem Diameter 130 mm Stem Length Trabecular Metal Humeral Stem 48 Degree 11mm x 130mm, Sterile, QTY 1, Rx Product Usage: Zimmer Trabecular Metal TM Humeral Stem is a shoulder prosthetic replacement device… |
| Product code | KWT |
| Recalling firm | Zimmer, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 11, 2014 |
| 510(k) numbers | K041549 |
| 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