FDA Device

Plicator EPS Plication System Catalog Number: 160-01128R

Hazard

Device arm may fail to open after being deployed and require surgical intervention to remove

What You Should Do

Remedy

NDO Surgical notified accounts by letter on 1/26/07 advising to quarantine units. Replacement units are being sent and recalled devices are requested to be returned.

Products

Plicator EPS Plication System Catalog Number: 160-01128R
Brand
NDO Surgical, Inc.
UPC
Serial Numbers: 43, 52, 54,59, 63, 65, 68, 72, 96,

Units Affected

9 units