Device recall
Z-0849-2014: Teflon Tube, sterile T2 Humerus System Stryker Trauma GmbH Prof Kuntscher Str…
FDA device recall · Class II · Stryker Howmedica Osteonics Corp.
Key facts
| Recall number (Z-number) | Z-0849-2014 |
|---|---|
| Recall event | 67055 |
| Product | Teflon Tube, sterile T2 Humerus System Stryker Trauma GmbH Prof Kuntscher Str 1-5 24232 Sconkidrchen, Germany distributed in the USA by: Stryker Howmedica Osteonics Corp.: Mahwah, NJ 07430 USA 510 K042396 Used in several T2 systems intended to support the exchange of the Ball Tip Guide Wires for… |
| Product code | HSB |
| Recalling firm | Stryker Howmedica Osteonics Corp. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 31, 2015 |
| 510(k) numbers | K042396 |
| FEI number | 3003070421 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 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