FDA Device recall Z-0989-2020
Coated VICRYL (Polyglactin 910) Suture, 18" (45cm) Product Code J497H. The device is a synthetic absorbable sterile surgical suture
- FDA Device
- Class II
- terminated
- Published 2020-02-12
On 2020-02-12 the FDA classified a Class II recall of Coated VICRYL (Polyglactin 910) Suture, 18" (45cm) Product Code J497H. The device is a synthetic absorbable sterile surgical suture by Ethicon, citing some sutures in the lot may exhibit a small section of braid fraying, which can lead to reduced tensile strength at that point.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0989-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-01-03 |
| Published | 2020-02-12 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Ethicon |
| Distribution | US |
Product
Coated VICRYL (Polyglactin 910) Suture, 18" (45cm) Product Code J497H. The device is a synthetic absorbable sterile surgical suture.
Reason
Some sutures in the lot may exhibit a small section of braid fraying, which can lead to reduced tensile strength at that point.
Identifiers
| code_info | lot PGZ908 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0989-2020%22
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