Z-0989-2020Class II

Coated VICRYL (Polyglactin 910) Suture, 18" (45cm) Product Code J497H. The device is a synthetic absorbable...

Name: Z-0989-2020 Coated VICRYL (Polyglactin 910) Suture, 18" (45cm) Product Code J497H. The device is a synthetic absorbable...
Creator: Ethicon, Inc.
Published: 2020-01-03
License: https://open.fda.gov/license/

Ethicon, Inc / initiated 2020-01-03 / Terminated / root cause: manufacturing process

FDA source

Ethicon, Inc. began a recall of Coated VICRYL (Polyglactin 910) Suture, 18" (45cm) Product Code J497H. The device is a synthetic absorbable sterile surgical suture on 2020-01-03. FDA classified it as Class II and gives the reason as "Some sutures in the lot may exhibit a small section of braid fraying, which can lead to reduced tensile strength at that point". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0989-2020
Classification: Class II
Status: Terminated
Initiated: 2020-01-03
Posted: 2020-02-04
Terminated: 2021-08-13
Recalling firm: Ethicon, Inc
Product: Coated VICRYL (Polyglactin 910) Suture, 18" (45cm) Product Code J497H. The device is a synthetic absorbable sterile surgical suture.
Product code: GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 23688 units
Distribution: Domestic distribution nationwide. US and Puerto Rico only.
Product codes and lots: lot PGZ908

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0989-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0989-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-04

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)