Device recall

Z-0524-06: Bard Composix Kugel Mesh X-Large Patch Oval with ePTFE, 8.7'' x 10.7'' Code…

FDA device recall · Class I · Davol, Inc., Sub. C. R. Bard, Inc.

Key facts

Recall number (Z-number) Z-0524-06
Recall event 34393
Product Bard Composix Kugel Mesh X-Large Patch Oval with ePTFE, 8.7'' x 10.7'' Code: 0010206
Product code FTL
Recalling firm Davol, Inc., Sub. C. R. Bard, Inc.
Recall class Class I
Status Completed
510(k) numbers K003323
FEI number 1213643

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

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