Z-1087-06

Coated Vicryl (polyglactin 910) suture. Needle Type CTXB Suture size: 1. Vicryl suture is a synthetic...

Name: Z-1087-06 Coated Vicryl (polyglactin 910) suture. Needle Type CTXB Suture size: 1. Vicryl suture is a synthetic...
Creator: Ethicon, Inc.
Published: 2006-05-04
License: https://open.fda.gov/license/

Ethicon, Inc / initiated 2006-05-04 / Terminated / root cause: packaging

FDA source

Ethicon, Inc. began a recall of Coated Vicryl (polyglactin 910) suture. Needle Type CTXB Suture size: 1. Vicryl suture is a synthetic absorbable sterile surgical suture comprised of a... on 2006-05-04. The reason FDA records is "Misalignment of packaging sealing platform created open seals and/or open channels in the packaging seal causing degradation of the sutures". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1087-06
Status: Terminated
Initiated: 2006-05-04
Posted: 2006-06-02
Terminated: 2007-12-17
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.
Product code: GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Reason for recall: Misalignment of packaging sealing platform created open seals and/or open channels in the packaging seal causing degradation of the sutures.
Root cause tag: packaging
FDA 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 in commerce: 1157 dozens
Distribution: Nationwide, Japan, Canada, and Taiwan.
Product codes and lots: Product Codes/Product Lot Numbers-Expiration Dates: J774D/SB2371-01/2008; JB725/SB2416-01/2008; J864D/SB2426-01/2008.

Product code GAM

K022269Class IICoated Vicryl* (Polyglactin 910) SutureETHICON, Inc. / cleared 2002-09-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)