Z-0021-2009

VICRYL RAPIDE (polyglactin 910) Braided Coated Synthetic Absorbable Suture, Undyed, Non-USP. Ethicon, Inc., a...

Name: Z-0021-2009 VICRYL RAPIDE (polyglactin 910) Braided Coated Synthetic Absorbable Suture, Undyed, Non-USP. Ethicon, Inc., a...
Creator: Ethicon, Inc.
Published: 2008-08-11
License: https://open.fda.gov/license/

Ethicon, Inc / initiated 2008-08-11 / Terminated / root cause: packaging

FDA source

Ethicon, Inc. began a recall of VICRYL RAPIDE (polyglactin 910) Braided Coated Synthetic Absorbable Suture, Undyed, Non-USP. Ethicon, Inc., a Johnson & Johnson Co.,Somerville, NJ 08876 The... on 2008-08-11. The reason FDA records is "Package defect compromised the integrity of the primary seal, which could lead to premature suture degradation and/or impair the sterile barrier of the product". 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-0021-2009
Status: Terminated
Initiated: 2008-08-11
Posted: 2008-10-02
Terminated: 2012-06-05
Recalling firm: Ethicon, Inc
Product: VICRYL RAPIDE (polyglactin 910) Braided Coated Synthetic Absorbable Suture, Undyed, Non-USP. Ethicon, Inc., a Johnson & Johnson Co.,Somerville, NJ 08876 The product is used for Soft Tissue approximation.
Product code: GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Reason for recall: Package defect compromised the integrity of the primary seal, which could lead to premature suture degradation and/or impair the sterile barrier of the product.
Root cause tag: packaging
FDA root cause: Packaging
Action: Letters were sent to distributors, Director of Surgery, Director of Risk Management, Director of Materials Management and Director of Operating Room on August 11, 2008, requesting that all affected lot numbers of Vicryl Rapide be discontinued immediately from sale and/or use. A separate correspondence was sent to hospitals. Letters to Director of Surgery, Director of Risk Management, Director of Materials Management and Director of Operating Rooms were advised of the recall and asked to discontinue use of any of the affected lot codes of sutures. Return and credit instructions were provided to the Director of Material Management. Contact Ethicon, Inc. at 1-908-218-2553 for assistance.
Quantity in commerce: 6912
Distribution: Worldwide: US and Canada OUS: Australia, New Zealand and Indonesia.
Product codes and lots: Product code V2920G, Lot ZE8KPMR0, Exp 6/30/2012; Product code PN1695H, Lot ZG8BDZQ0, Exp. 6/30/2012; Product code V2920H, Lot ZG8BJQR0, Exp 6/30/2012; Product code V4731H, Lot ZG8BSSQ0, Exp 6/30/2012; Product code VR214, Lot ZG8BTSD0, Exp. 6/30/2012; Product code W9947, Lot ZG8BHPQ0, Exp 6/30/2012; Product code VR214, Lot ZG9CJXD0, Exp. 6/06/2012; Product code V4851H, Lot ZG8BZWQ0, Exp. 6/30/2012 and Product code VR426, Lot ZG9BSPE0, Exp. 6/4/2012.

Product code GAM

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)