Recall Z-1608-2010 ยท GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Ethicon, Inc.
Coated VICRYL RAPIDE (polyglactin 910) Braided Coated Synthetic Absorbable Suture, Undyed. Intended use: Soft Tissue approximation.
| Date | May 18, 2010 (initiated Apr 20, 2010) |
| Status | Terminated |
| Reason | Channels in the packaging seal that can lead to suture degradation and loss of packaging integrity. Recall Z-0021-2009 was initiated in 2008. Ethicon had decided to recall all sutures product during the may to June 2007 timeframe. |
| Root cause | Other |
| Action | "Expansion of 2008 Voluntary Recall" notification letters dated April 20, 2010 were sent by second day UPS to customers, distributors, Materials Managers, Director of Surgical Services, and Directors of Risk Management. The letters state that the expansion includes 37 lots of products. The letters describe the product, problem and action t to be taken by customers. The customers were instructed to immediately discontinue use of any of the affected product and to remove from all inventory and returned to Stericycle. If they are not returning product, they should mail the enclosed business r |
| Quantity | 118332 eaches were sent to the US Distribution Center, of which 69936 eaches were shipped to primary consignees. |
| Distribution | Worldwide distribution: USA and Austria, Belgium, Canada, Chile, China, Czech Republic, Egypt, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Japan, Korea, Malaysia, Middle East, Netherlands Antilles, New Zealand, Poland, Portugal, Russia, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Sw |
| FDA record | Open on fda.gov |