Device recall
Z-2543-2011: Comprehensive reverse shoulder humeral tray with locking ring, 44 mm +10 mm…
FDA device recall · Class II · Biomet, Inc.
Key facts
| Recall number (Z-number) | Z-2543-2011 |
|---|---|
| Recall event | 58571 |
| Product | Comprehensive reverse shoulder humeral tray with locking ring, 44 mm +10 mm, sterile, single use, REF 115348, Biomet Orthopedics, Warsaw, IN. Biomet Comprehensive Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe… |
| Product code | KWS |
| Recalling firm | Biomet, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 21, 2013 |
| 510(k) numbers | K080642 |
| 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