Device recall
Z-0080-2008: ReUnion Fracture Stem Humeral Component - PureFix HA; Shoulder prosthesis…
FDA device recall · Class II · Stryker Howmedica Osteonics Corp.
Key facts
| Recall number (Z-number) | Z-0080-2008 |
|---|---|
| Recall event | 38775 |
| Product | ReUnion Fracture Stem Humeral Component - PureFix HA; Shoulder prosthesis. Distal Diameter - 7 to 15mm; Hydroxylapatite coated; Titanium Plasma Spray; Howmedica Osteonics Corp. |
| Product code | KWS |
| Recalling firm | Stryker Howmedica Osteonics Corp. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 7, 2008 |
| 510(k) numbers | K062113 |
| 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