Device recall
Z-2164-2009: Restoration Modular Hip System; Proximal Cone Body; 29 mm +0 mm (STD); Not for…
FDA device recall · Class III · Stryker Howmedica Osteonics Corp.
Key facts
| Recall number (Z-number) | Z-2164-2009 |
|---|---|
| Recall event | 52713 |
| Product | Restoration Modular Hip System; Proximal Cone Body; 29 mm +0 mm (STD); Not for use with + 16 V40 femoral Head. For Cementless Use Only. Stryker Orthopaedics. Intended to be used for primary or revision total hip arthroplasty as well as in the presence of sever proximal bone loss. |
| Product code | LZO |
| Recalling firm | Stryker Howmedica Osteonics Corp. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jul 27, 2010 |
| 510(k) numbers | K013106 |
| FEI number | 3003070421 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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