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Terminated

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.

FDA Recall Z-0907-06 · Posted 2006-05-27

Recalling FirmEthicon, Inc.
Recall StatusTerminated
Product CodeGAM
Date Initiated2006-02-16
Date Terminated2006-12-07
Product Quantity1,061,712 sutures

Reason for Recall

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.

Firm Action

Customer notification letter was sent out on 3/28/2006 alerting the customer to the problem with the suture.

Root Cause

Other

Distribution Pattern

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 Australia, Canada, Hong Kong, Indonesia, Japan, Korea, Malaysia, Philippines, Taiwan, and Thailand.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K974299PANACRYLETHICON, Inc. · 1998-02-13K964345ETHICON ABSORBABLE POLY (L-LACTIDE/GLYCOLIDE) SURGICAL SUTURE, UNDYEDETHICON, Inc. · 1996-12-16

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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