RecallRadar

FDA Device recall Z-0818-2016

High Flow Irrigation Extender

On 2016-02-24 the FDA classified a Class II recall of High Flow Irrigation Extender by Smith And Nephew Endoscopy Div, citing during arthroscopic surgery, when the scope is moved inside the cannula, the body of the irrigation extender separates, potentially obstructing visualization and causing leakage o….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0818-2016
ClassificationClass II
Statusterminated
Initiated2013-07-30
Published2016-02-24
Last updated2026-09-13 11:54 UTC
CompanySmith And Nephew Endoscopy Div
DistributionAK, AL, AR, CA, FL, GA, ID, IL, KS, MA, MI, MO, NC, TN, TX

Product

High Flow Irrigation Extender; Part Number 72201021. Arthroscopic accessories are indicated for use in access of the joint capsule.

Reason

During arthroscopic surgery, when the scope is moved inside the cannula, the body of the irrigation extender separates, potentially obstructing visualization and causing leakage of the irrigation fluid. The device is removed and a back-up device is used to complete the surgery.

Identifiers

code_info
50209581 50220887 50231401 50216929 50226220 50231932 50218285 50229266 50235063 50240019 50245683 50251109 50254562 50…50209581 50220887 50231401 50216929 50226220 50231932 50218285 50229266 50235063 50240019 50245683 50251109 50254562 50256942 50263784 50279382 50291593 50302984 50303418 50327069 50330377 50351345 50361381 50404796 50408768 50419699 50433964 50250837 50256854 50269580 5027766 50304642 50342002 50401593 50417254

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0818-2016%22

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