Device recall
Z-1367-2009: Accolade TMZF Plus Hip Stem; Hydroxylapatite coated, Titanium Plasma Spray; V40…
FDA device recall · Class II · Stryker Howmedica Osteonics Corp.
Key facts
| Recall number (Z-number) | Z-1367-2009 |
|---|---|
| Recall event | 50901 |
| Product | Accolade TMZF Plus Hip Stem; Hydroxylapatite coated, Titanium Plasma Spray; V40 taper Longitudinal Grooves, Stem Length 120mm, Head Offset - 43mm, 127 degree neck angle. Hip stems are single use devices intended for cementless fixation. The products are intended for use in primary reconstruction of… |
| Product code | MEH |
| Recalling firm | Stryker Howmedica Osteonics Corp. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 25, 2012 |
| 510(k) numbers | K023102 |
| 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