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Terminated

FMsealer Open Shears. Model FM3001

FDA Recall Z-0690-2017 · Posted 2016-12-01

Recalling FirmDomain Surgical, Inc.
Recall StatusTerminated
Product CodeGEI
Date Initiated2016-10-24
Date Terminated2017-04-11
Product Quantity70 units US; 175 units OUS

Reason for Recall

Domain Surgical, Inc. announces a voluntary field action for the FMsealer Open Shears due to fixed jaw fractures during clincal usage.

Firm Action

Consignees were notified on 10/24/2016 via letter to return affected products to Domain Surgical, Inc.

Root Cause

Other

Distribution Pattern

Nationwide and other foreign consignees. No Canadian or VA/govt/military consignees.

Official Source

View FDA Recall →

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

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