Device recall
Z-1003-2012: Custom surgical kits: DeRoyal(R) TRAUMA CRANIOTOMY PACK, REF 89-7639.01, STERILE…
FDA device recall · Class II · DeRoyal Processing Center
Key facts
| Recall number (Z-number) | Z-1003-2012 |
|---|---|
| Recall event | 61038 |
| Product | Custom surgical kits: DeRoyal(R) TRAUMA CRANIOTOMY PACK, REF 89-7639.01, STERILE EO, Manufactured by: DeRoyal Industries, Inc., Powell, TN 37849 DeRoyal(R) TRAUMA CRANIOTOMY PACK PGYBK, REF 89-7639.01, STERILE EO, Manufactured by: DeRoyal Industries, Inc., Powell, TN 37849 DeRoyal(R) TRAUMA… |
| Product code | LRP |
| Recalling firm | DeRoyal Processing Center |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 5, 2012 |
| FEI number | 1000208624 |
At a glance
- None 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