FDA Medical Device Recalls (openFDA)
Ethicon, Inc.: Coated Vicryl (polyglactin 910) suture. Needle Type CTXB Suture size: 1. Vicryl suture is a synthetic absorbable sterile surgical suture comprised of a copolymer made from 90% gycolide and 10%L-lactide.
- Recall number
- Z-1087-06
- Recalling firm
- Ethicon, Inc.
- Product
- Coated Vicryl (polyglactin 910) suture. Needle Type CTXB Suture size: 1. Vicryl suture is a synthetic absorbable sterile surgical suture comprised of a copolymer made from 90% gycolide and 10%L-lactide.
- Status
- Terminated
- Initiated
- 2006-05-04
- Posted
- 2006-06-02
- Terminated
- 2007-12-17
- Reason
- Misalignment of packaging sealing platform created open seals and/or open channels in the packaging seal causing degradation of the sutures.
- Root cause
- Other
- Action
- The firm sent out recall notification on 5/4/2006. The US consignees were sent a letter via return receipt.
- Quantity
- 1157 dozens
- Distribution
- Nationwide, Japan, Canada, and Taiwan.
- Lot, serial or model codes
- Product Codes/Product Lot Numbers-Expiration Dates: J774D/SB2371-01/2008; JB725/SB2416-01/2008; J864D/SB2426-01/2008.
- 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