Diamond Burr with Coarse and Extra-Coarse Grain 의 안전성 경고

Safety alert

2017-283

Philippines

FDAP

https://ww2.fda.gov.ph//index.php/advisories-2/medical-devices-advisories-pertaining-to-all-regulated-medical-devices/468818-fda-advisory-no-2017-283

Fda advisory no. 2017-283  voluntary recall of diamond burr with coarse and extra-coarse grain (pursuant to system) all concerned healthcare professionals are hereby advised by the food and drug administration (fda) regarding the voluntary recall of diamond burr (see photos of the product below) distributed by b. braun medical supplies, inc. diamond burrs are used in spine surgery and cranial neurosurgery in the area of working on hard tissue. the following list of affected articles: gp161r elan 4 1-ring diamond burr coarse d2.0gp162r elan 4 1-ring diamond burr+ coarse d2.0gp163r elan 4 1-ring diamond burr coarse d2,3gp164r elan 4 1-ring diamond burr+ coarse d2,3gp165r elan 4 1-ring diamond burr coarse d3,0gp166r elan 4 1-ring diamond burr+ coarse d3,0gp167r elan 4 1-ring diamond burr++ coarse d3,0gp168r elan 4 1-ring diamond burr coarse d4,0gp169r elan 4 1-ring diamond burr coarse d5,0gp170r elan 4 1-ring diamond burr coarse d6,0gp321r elan 4 2-ring diamond burr coarse d2.3gp322r elan 4 2-ring diamond burr coarse d3.0gp323r elan 4 2-ring diamond burr coarse d4.0gp324r elan 4 2-ring diamond burr coarse d5.0gp325r elan 4 2-ring diamond burr coarse d6.0ge426r hi-line xs diamond burr x-crs.I d4.5mmge426su hi-line xs disp.Diam.Burr x-crs.I d4.5mmge526r hi-line xs diamond burr x-crs.Ii d4.5mmge526su hi-line xs disp.Diam.Burr x-crs.Ii d4.5ge626r hi-line xs diamond burr x-crs.Iii d4.5mmge626su hi-line xs disp.Diam.Burr x-crs.Iii d4.5gp173r elan 4 1-ring diamond burr x-coarse d3,0gp174r elan 4 1-ring diamond burr x-coarse d4,0gp175r elan 4 1-ring diamond burr x-coarse d5,0gp176r elan 4 1-ring diamond burr x-coarse d6,0gp177r elan 4 1-ring diamond burr x-coarse d7,0gp328r elan 4 2-ring diamond burr x-coarse d4.0gp329r elan 4 2-ring diamond burr x-coarse d5.0gp330r elan 4 2-ring diamond burr x-coarse d6.0 the above-stated medical device products are being voluntary recalled by b. braun medical supplies, inc. the use of these tools under some conditions can result in the release of particles from the diamond coating, which may not be discovered by the user. it was observed that during operation particles can break out oneself from the diamond burr fall into the situs. if the particles are not detected after breaking out and thus are not removed from the wound the particles can remain to a certain extent in the patient’s body. distributors, retailers, hospitals and all healthcare professionals/users are advised to discontinue further distribution, sale and use of the said affected medical device product. for more information and inquiries, please email us at this email address is being protected from spambots. you need javascript enabled to view it. or call the product research and standards development division of the fda - center for device regulation, radiation health and research at 857-1900 local 8301. dissemination of the information to all concerned is requested.     attachments: fda advisory no. 2017-283.Pdf.