Device recall
Z-1063-2014: Gelzone Shoulder Sleeve, Catalog Number SLV634, Lot Number 852766. Product…
FDA device recall · Class II · Implantech Associates Inc
Key facts
| Recall number (Z-number) | Z-1063-2014 |
|---|---|
| Recall event | 67446 |
| Product | Gelzone Shoulder Sleeve, Catalog Number SLV634, Lot Number 852766. Product Usage: To be used where limb support and/or elevation is considered necessary. |
| Product code | HST |
| Recalling firm | Implantech Associates Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 12, 2015 |
| FEI number | 1000142697 |
At a glance
- None 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