Device recall
Z-2334-2020: smith&nephew R3 THREE HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL…
FDA device recall · Class II · Smith & Nephew, Inc.
Key facts
| Recall number (Z-number) | Z-2334-2020 |
|---|---|
| Recall event | 85637 |
| Product | smith&nephew R3 THREE HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 42MM 71331942 46MM 71331946 48MM 71331948 50MM 71331950 52MM 71331952 54MM 71331954 56MM 71331956 58MM 71331958 60MM 71331960 62MM 71331962 64MM 71331964 68MM… |
| Product code | MBL |
| Recalling firm | Smith & Nephew, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K070756 |
| FEI number | 1020279 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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