Device recall
Z-0736-2023: Full Dose CE Simplex P Single Bone Cement - Indicated for the fixation of…
FDA device recall · Class III · Howmedica Osteonics Corp.
Key facts
| Recall number (Z-number) | Z-0736-2023 |
|---|---|
| Recall event | 91147 |
| Product | Full Dose CE Simplex P Single Bone Cement - Indicated for the fixation of prostheses to living bone in orthopaedic Catalog Number: 6191-0-001 |
| Product code | LOD |
| Recalling firm | Howmedica Osteonics Corp. |
| Recall class | Class III |
| Status | Open, Classified |
| 510(k) numbers | K002652 |
| FEI number | 3003070421 |
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