Device recall
Z-0475-2021: iTotal Hip Replacement System, Model number HAA-050-D020-020102 The Conformis…
FDA device recall · Class II · Conformis, Inc.
Key facts
| Recall number (Z-number) | Z-0475-2021 |
|---|---|
| Recall event | 86615 |
| Product | iTotal Hip Replacement System, Model number HAA-050-D020-020102 The Conformis Hip System includes standard hip replacement components as well as the following patient specific components: femoral stem and single use instrumentation. |
| Product code | LPH |
| Recalling firm | Conformis, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 12, 2023 |
| 510(k) numbers | K192198 |
| FEI number | 3009844603 |
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