Device recall
Z-1511-2021: DONJOY REF:11-0447-9-ULTRASLING PRO, UNIVERSAL, Rx ONLY, UDI:(01)00190446673552…
FDA device recall · Class II · DJ Orthopedics de Mexico S.A. de C.V.
Key facts
| Recall number (Z-number) | Z-1511-2021 |
|---|---|
| Recall event | 87727 |
| Product | DONJOY REF:11-0447-9-ULTRASLING PRO, UNIVERSAL, Rx ONLY, UDI:(01)00190446673552 - Product Usage: intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck. |
| Product code | ILI |
| Recalling firm | DJ Orthopedics de Mexico S.A. de C.V. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 21, 2024 |
| FEI number | 3017264244 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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