| ||Class 2 Recall|
Coated VICRYL (Polyglactin 910) Suture
||May 12, 2009
||Terminated on October 21, 2009
|Recall Event ID
Suture, Absorbable, Synthetic, Polyglycolic Acid - Product Code GAM
||Coated VICRYL (Polyglactin 910) Suture, Ethicon Inc., A Johnson & Johnson Company, Somerville, NJ 08876
Sutures are intended for general soft tissue approximation and/or ligation.
US Highway 22 West
Somerville, New Jersey 08876
|For Additional Information Contact
|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.
|PRODUCTION CONTROLS: Process Control
||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
||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.
|Total Product Life Cycle
TPLC Device Report
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K)s with Product Code = GAM and Original Applicant = Depuy Mitek
510(K)s with Product Code = GAM and Original Applicant = ETHICON, INC.