Recall Z-1316-2009 ยท NEW Suture, Surgical, Absorbable, Polydioxanone
Ethicon, Inc.
Orthocord Suture, DePuy Mitek, a Johnson & Johnson Company; . DePuy Mitek, Inc. 325 Paramount Drive, Raynham, MA 02767 Sutures are intended for general soft tissue approximation and/or ligation.
| Date | May 12, 2009 (initiated Feb 2, 2009) |
| Status | Terminated |
| Reason | 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 | 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 |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040004 | ORTHOCORD SUTURE Depuy Mitek, Apr 13, 2004 |