Recall Z-0907-06 ยท GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Ethicon, Inc.
Panacryl Synthetic Absorbable Suture. Poly(L-lactide/glycolide) Suture. Undyed (white), braided, this suture is a synthetic absorbable sterile surgical suture composed of a copolymer of 95% lactide and 5% glycolide. The suture is coated with a copolymer composed of 90% caprolactone and 10% glycolide.
| Date | May 27, 2006 (initiated Feb 16, 2006) |
| Status | Terminated |
| Reason | The unique absorption profile of Panacryl in the suture could act as a foreign body so that surgeons should consider its use in specific situations. |
| Root cause | Other |
| Action | Customer notification letter was sent out on 3/28/2006 alerting the customer to the problem with the suture. |
| Quantity | 1,061,712 sutures |
| Distribution | There were 2202 customers in the US and 10 international customers. This product is no longer being marketed by Ethicon. Its last shipment was 7/1/2002. There are US Military and VA Hospitals included. All International customers are the J&J Medical Products Distribution Ctrs located in Australi |
| FDA record | Open on fda.gov |