Device recall
Z-0609-2014: Trabecular Metal (TM) Reverse Glenosphere 36mm Part 00-4349-036-11 The reverse…
FDA device recall · Class II · Zimmer, Inc.
Key facts
| Recall number (Z-number) | Z-0609-2014 |
|---|---|
| Recall event | 66968 |
| Product | Trabecular Metal (TM) Reverse Glenosphere 36mm Part 00-4349-036-11 The reverse shoulder system is used in the treatment of the following: severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint; un-united humeral head fractures of long… |
| Product code | KWT |
| Recalling firm | Zimmer, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 11, 2014 |
| 510(k) numbers | K130661 |
| 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