Z-1311-2009

MONOCRYL (poliglecaprone 25 ) Suture, Ethicon Inc., A Johnson & Johnson Company, Somerville, NJ Sutures are...

Name: Z-1311-2009 MONOCRYL (poliglecaprone 25 ) Suture, Ethicon Inc., A Johnson & Johnson Company, Somerville, NJ Sutures are...
Creator: Ethicon, Inc.
Published: 2009-02-02
License: https://open.fda.gov/license/

Ethicon, Inc / initiated 2009-02-02 / Terminated / root cause: manufacturing process

FDA source

Ethicon, Inc. began a recall of MONOCRYL (poliglecaprone 25 ) Suture, Ethicon Inc., A Johnson & Johnson Company, Somerville, NJ Sutures are intended for general soft tissue approximation... on 2009-02-02. The reason FDA records is "Sterility Issue: The firm decided to remove the product because it cannot assure the sterility of the products due to a failure in the sterilization process". 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-1311-2009
Status: Terminated
Initiated: 2009-02-02
Posted: 2009-05-12
Terminated: 2009-10-21
Recalling firm: Ethicon, Inc
Product: MONOCRYL (poliglecaprone 25 ) Suture, Ethicon Inc., A Johnson & Johnson Company, Somerville, NJ Sutures are intended for general soft tissue approximation and/or ligation.
Product code: GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Reason for recall: Sterility Issue: The firm decided to remove the product because it cannot assure the sterility of the products due to a failure in the sterilization process.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Urgent Voluntary Product Recall notification letters were sent via UPS Next Day Air with receipt on February 2, 2009. Letters were sent to customers, Directors of Surgical Services, Director of Risk Management, Materials Manager and Distributors. The letters requested that customers immediately discontinue use of the products with lot numbers listed. Customers are to identify and return only the boxes identified in the attached tables. The affected product should be returned to Ethicon via the pre-paid authorized shipping label. Customers that are not returning affected product should mail the enclosed business reply card to Ethicon. Customers should direct questions regarding this recall to 1-888-202-3694 or their Ethicon sales representative. 5/13/09: It was discovered that a lot of PDS II sutures that had been previously identified as affected but not distributed, were mistakenly distributed. Revised letters including this number were sent to 25 customers on 5/13/09.
Quantity in commerce: 1,758,360 total
Distribution: Worldwide Distribution -- USA, Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, Greece, Hong Kong, Israel, Japan, Korea, Luxemburg, Mexico, New Zealand, Norway, Panama, Puerto Rico, Sweden, Taiwan, United Kingdom, Uruguay, and Venezuela.
Product codes and lots: Lot # APZ334, APM964, APM965, APZ063, APZ155, APZ156, and APZ476.

Product code GAM

K960653Class IIMonocryl (Poliglecaprone 25) Suture, Dyed (Modified)ETHICON, Inc. / cleared 1996-03-28

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)