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Terminated

Dermagraft, Human Fibroblast -Derived Dermal Substitute, 2 in. by 3 in..

FDA Recall Z-0904-03 · Posted 2003-06-04

Recalling FirmSmith and Nephew Wound Management (La Jolla)
Recall StatusTerminated
Product CodeMGR
Date Initiated2003-05-02
Date Terminated2003-11-03
Product Quantity22

Reason for Recall

Did not meet finished device specifications for the DNA criteria.

Firm Action

Recall was by telephone on or about May 2, 2003 and by letter on May 7, 2003. Product is to be returned.

Root Cause

Other

Distribution Pattern

To hospitals nationwide.

Official Source

View FDA Recall →

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

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