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.
Other recalls by Ethicon
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FDA Device · Class II · 2025-10-01 · Ethicon - PERMA-HAND Silk Suture, REF: K872H, W723H, 623H, K833H
FDA Device · Class II · 2025-02-12 · Ethicon - ETHIBOND EXCEL Polyester Suture, REF: 6664H, X425H, X872H, EH7491H. Not sold in US
FDA Device · Class II · 2025-02-12 · Ethicon - PROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLENE Suture is indicated for use in general soft tissue approxima…
FDA Device · Class II · 2025-02-12 · Ethicon
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0989-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.