Device recall
Z-0227-2026: iNSitu Bipolar Hip System, Bipolar head implant Part ID Description 10-22-0038…
FDA device recall · Class II · Theken Companies LLC
Key facts
| Recall number (Z-number) | Z-0227-2026 |
|---|---|
| Recall event | 97676 |
| Product | iNSitu Bipolar Hip System, Bipolar head implant Part ID Description 10-22-0038 Bipolar Head Assembly, Size 38mm 10-22-0040 Bipolar Head Assembly, Size 40mm 10-22-0042 Bipolar Head Assembly, Size 42mm 10-22-0044 Bipolar Head Assembly, Size 44mm 10-22-0046 Bipolar Head Assembly, Size 46mm 10-22-0048… |
| Product code | MEH |
| Recalling firm | Theken Companies LLC |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K191297, K241875 |
| FEI number | 3002498892 |
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