Device recall
Z-0095-2018: iBalance(R) UKA, Femoral Cemented, Size 3, Left Medial/Right LATERAL, REF AR…
FDA device recall · Class II · Arthrex, Inc.
Key facts
| Recall number (Z-number) | Z-0095-2018 |
|---|---|
| Recall event | 78297 |
| Product | iBalance(R) UKA, Femoral Cemented, Size 3, Left Medial/Right LATERAL, REF AR 501-UFLC, QTY 1, Rx ONLY, STERILE R, Arthrex, Inc., Naples, FL Indicated for use in uni-compartmental knee arthroplasty as a result of: 1. Moderately disabling joint disease of the knee resulting from painful osteoarthritis… |
| Product code | HSX |
| Recalling firm | Arthrex, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 4, 2018 |
| 510(k) numbers | K060670 |
| FEI number | 1220246 |
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