Device recall
Z-2148-2024: MONOCRYL (poliglecaprone 25) Suture - Intended for use in general soft tissue…
FDA device recall · Class II · Ethicon, Inc.
Key facts
| Recall number (Z-number) | Z-2148-2024 |
|---|---|
| Recall event | 94643 |
| Product | MONOCRYL (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is indicated PRODUCT CODE: Y315H Y345H Y359H Y398H Y416H Y417H Y426H Y427H Y935H Y936H Y945H |
| Product code | GAN |
| Recalling firm | Ethicon, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K960653, K964072 |
| FEI number | 3017102971 |
At a glance
- 1–9 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