Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Completed

Bard Composix Kugel Hernia Patch- Large Oval with ePTFE , 5.4'' x 7.0'' Product Number: 0010202

FDA Recall Z-0359-2007 · Posted 2007-01-30

Recalling FirmDavol, Inc., Sub. C. R. Bard, Inc.
Recall StatusCompleted
Product CodeFTL
Date Initiated2007-01-10
Product Quantity32,581 units

Reason for Recall

PET recoil ring breakage-Memory recoil ring may break which could potentially lead to bowel perforation and or chronic enteric fistula

Firm Action

Davol Inc. notified Hospital Administrators/Risk Health Managers,distributors, and surgeons of the expanded recall by letter beginning 1/10/07. Product under recall is to be returned to Davol for replacement. Davol is posting recall information to their website.

Root Cause

Other

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K003323COMPOSIX KUGEL MESH, MODEL 0010201,0010202,0010203,0010204,0010205Davol, Inc. · 2001-01-22

Official Source

View FDA Recall →

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

↑