Device recall
Z-1533-2024: STRATAFIX Spiral MONOCRYL Plus Bidirectional Knotless Tissue Control Device…
FDA device recall · Class II · Ethicon, Inc.
Key facts
| Recall number (Z-number) | Z-1533-2024 |
|---|---|
| Recall event | 94220 |
| Product | STRATAFIX Spiral MONOCRYL Plus Bidirectional Knotless Tissue Control Device: STRATAFIX SPIRAL MONOCRYL PLUS BI UD 12+12IN(30+30CM) USP3-0(M2) D/A PS PRM- Indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate. Product Code: SXMP2B412 |
| Product code | GAM |
| Recalling firm | Ethicon, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K192580 |
| FEI number | 3017102971 |
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