Device recall
Z-1918-2012: LUSTER HIP SZ 4 Packaging: The product was packaged within inner and outer…
FDA device recall · Class II · DePuy Orthopaedics, Inc.
Key facts
| Recall number (Z-number) | Z-1918-2012 |
|---|---|
| Recall event | 61749 |
| Product | LUSTER HIP SZ 4 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are forged CoCr polished… |
| Product code | JDI |
| Recalling firm | DePuy Orthopaedics, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 5, 2013 |
| 510(k) numbers | K983136 |
| FEI number | 1818910 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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