Device recall
Z-0931-2012: Duration packaging distributed by Stryker Orthopaedics, Limerick, Ireland…
FDA device recall · Class II · Stryker Howmedica Osteonics Corp.
Key facts
| Recall number (Z-number) | Z-0931-2012 |
|---|---|
| Recall event | 60850 |
| Product | Duration packaging distributed by Stryker Orthopaedics, Limerick, Ireland Stryker Ireland Carrigtwohill Industrial Estate Carrigtwohill County Cork, Ireland Product Usage: Orthopaedic implants utilized for primary and revision hip and knee (total and unilateral); total shoulder and elbow… |
| Product code | MEH |
| Recalling firm | Stryker Howmedica Osteonics Corp. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 17, 2015 |
| 510(k) numbers | K112556 |
| 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