Coated Vicryl (polyglactin 910) suture. Needle Type CTXB Suture size: 1. Vicryl suture is a synthetic absorbable sterile surgical suture comprised of a copolymer made from 90% gycolide and 10%L-lactide.
FDA Recall Z-1087-06 · Posted 2006-06-02
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Recalling FirmEthicon, Inc.
Recall StatusTerminated
Product CodeGAM
Date Initiated2006-05-04
Date Terminated2007-12-17
Product Quantity1157 dozens
Reason for Recall
Misalignment of packaging sealing platform created open seals and/or open channels in the packaging seal causing degradation of the sutures.
Firm Action
The firm sent out recall notification on 5/4/2006. The US consignees were sent a letter via return receipt.
Root Cause
Other
Distribution Pattern
Nationwide, Japan, Canada, and Taiwan.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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