Device recall
Z-0320-2011: Straumann T-Sleeve 2.8mm, height 6mm, guided Article Number: 034.055V46 Intended…
FDA device recall · Class III · Straumann Manufacturing Inc.
Key facts
| Recall number (Z-number) | Z-0320-2011 |
|---|---|
| Recall event | 52231 |
| Product | Straumann T-Sleeve 2.8mm, height 6mm, guided Article Number: 034.055V46 Intended for use as a drilling guide to prepare a site for placement of a dental implant into the dental implant site. |
| Product code | NDP |
| Recalling firm | Straumann Manufacturing Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Feb 20, 2012 |
| FEI number | 1000121052 |
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