Device recall
Z-2291-2021: The Aequalis Pyrocarbon Humeral Heads. Shoulder implant component. Sold OUS…
FDA device recall · Class II · Tornier S.A.S.
Key facts
| Recall number (Z-number) | Z-2291-2021 |
|---|---|
| Recall event | 88174 |
| Product | The Aequalis Pyrocarbon Humeral Heads. Shoulder implant component. Sold OUS only: a) Catalog # DWH039 - Diameter 39 mm Height 14 mm Eccentric LOW (1.5) Material PyC/CoCr, b) Catalog # DWH041 - Diameter 41 m m Height 15 mm Eccentric LOW (1.5) Material PyC/CoCr, c) Catalog # DWH043 - Diameter 43 mm… |
| Product code | QHE |
| Recalling firm | Tornier S.A.S. |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 3000931034 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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