FDA Medical Device Recalls (openFDA)
Ethicon, Inc.: Coated VICRYL (Polyglactin 910) Suture, 18" (45cm) Product Code J497H. The device is a synthetic absorbable sterile surgical suture.
- Recall number
- Z-0989-2020
- Recalling firm
- Ethicon, Inc.
- Product
- Coated VICRYL (Polyglactin 910) Suture, 18" (45cm) Product Code J497H. The device is a synthetic absorbable sterile surgical suture.
- Status
- Terminated
- Initiated
- 2020-01-03
- Posted
- 2020-02-04
- Terminated
- 2021-08-13
- Reason
- Some sutures in the lot may exhibit a small section of braid fraying, which can lead to reduced tensile strength at that point.
- Root cause
- Process control
- Action
- The firm notified customers of the recall on January 3, 2020. Customers were informed to immediately cease usage or distribution of the recalled lot. All unused product subject to the recall is to be returned to the firm. If any recalled product was forwarded to another facility, contact that facility to arrange return. Customers were also asked to complete and return the included business reply form to the recalling firm even if they did not have product subject to this recall. In addition, customers are to keep the recall notice visibly posted for awareness until all product subject to this recall has been returned to Stericycle. If you require any assistance with returning product, please contact Stericycle at 877-550-0701 and reference Event # 3453. Health care practitioners who have treated patients using this product should follow those patients post-operatively in the usual manner with no additional action required. If you have additional questions regarding this recall or to report any customer complaints, please contact Ethicon Customer Support Center at 1-877-ETHICON (1-877-384-4266). The Customer Support Center is open Monday through Friday, 7:30 AM to 6:30 PM ET.
- Quantity
- 23688 units
- Distribution
- Domestic distribution nationwide. US and Puerto Rico only.
- Lot, serial or model codes
- lot PGZ908
- 510(k) numbers
- ["K022269"]
- PMA numbers
- not on file
- Product code
- GAM
- Firm FEI
- 2210968
- Firm city
- Somerville
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28