Device recall
Z-0619-2021: Comprehensive Reverse Shoulder System, Item numbers 115394, 115395, 115396…
FDA device recall · Class II · Biomet, Inc.
Key facts
| Recall number (Z-number) | Z-0619-2021 |
|---|---|
| Recall event | 86896 |
| Product | Comprehensive Reverse Shoulder System, Item numbers 115394, 115395, 115396, 115398, 180550, 180551, 180552, 180553, 180554, 180555, 180556, 180557, 180558, 180559, 180560, 180562 - Product Usage: 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 | May 8, 2024 |
| 510(k) numbers | K130390, K132239, K193373 |
| 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