Device recall
Z-1128-2018: U2 Total Knee System Tibial Insert, Posterior Stabilized, #3, 11mm Thick…
FDA device recall · Class II · United Orthopedic Corporation
Key facts
| Recall number (Z-number) | Z-1128-2018 |
|---|---|
| Recall event | 79321 |
| Product | U2 Total Knee System Tibial Insert, Posterior Stabilized, #3, 11mm Thick Catalogue number 2303-3032 The U2 Total Knee system is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to… |
| Product code | JWH |
| Recalling firm | United Orthopedic Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 9, 2018 |
| 510(k) numbers | K051640 |
| FEI number | 1000395711 |
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