Coated VICRYL — Class II medical device recall Z-0989-2020
Terminated recall by Ethicon, Inc., reported 2020-02-12, distributed nationwide. Some sutures in the lot may exhibit a small section of braid fraying, which can lead to reduced tensile streng
| Recall number | Z-0989-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ethicon, Inc., Somerville, NJ, United States |
| Recall initiated | 2020-01-03 |
| Classified | 2020-02-04 |
| Reported by FDA | 2020-02-12 |
| Terminated | 2021-08-13 |
| Distributed | Nationwide (US) |
| Quantity | 23,688 units |
| Reason classes | potency |
| Lot numbers | PGZ908 |
Product
Coated VICRYL (Polyglactin 910) Suture, 18" (45cm) Product Code J497H. The device is a synthetic absorbable sterile surgical suture.
Reason for recall
Some sutures in the lot may exhibit a small section of braid fraying, which can lead to reduced tensile strength at that point.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0989-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.