RecallRadar

FDA Device recall Z-0820-2014

Composix L/P with Echo PS 6" X 8" Product Code 0144680 The Composix L/P Mesh with Echo PS Positioning System is a non-absorbable sterile li…

On 2014-01-29 the FDA classified a Class II recall of Composix L/P with Echo PS 6" X 8" Product Code 0144680 The Composix L/P Mesh with Echo PS Positioning System is a non-absorbable sterile li… by Davol Subs C R Bard, citing product labeling does not match product configuration.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0820-2014
ClassificationClass II
Statusterminated
Initiated2014-01-03
Published2014-01-29
Last updated2026-09-13 11:53 UTC
CompanyDavol Subs C R Bard
DistributionUS

Product

Composix L/P with Echo PS 6" X 8" Product Code 0144680 The Composix L/P Mesh with Echo PS Positioning System is a non-absorbable sterile lightweight mesh prosthesis, with a preattached removable positioning system. This system is indicated and designed for the reconstruction of soft tissue deficiencies during laproscopic ventral hernia repair.

Reason

Product labeling does not match product configuration.

Identifiers

code_infoLot# HUXG0491, HUXH0295

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0820-2014%22

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