FDA-Device2019-09-25Class II
AD-TECH Drill Sleeve Guides, used with Ad-Tech Placement Kits: (a) REF DSG-90-2.3N (b) REF DSG-6.3-090-2.4N
Ad-Tech Medical Instrument Corporation
Hazard
The inner diameter of the drill sleeve guide raw material was found to be under tolerance, potentially resulting in the drill bit seizing in the guide during surgery.
Sold states
NY, PA, WI, AZ, IL, CA, NH, GA, MA, MN, UT, MI, WA, FL, TX, OH, OR, PA, MD, and India, Korea, Taiwan, Canada, Hong Kong, Denmark, Russia, Singapore, Japan, Brazil. UK, Spain, Czech Republic, France
Affected count
315 units
Manufactured in
400 W Oakview Pkwy, N/A, Oak Creek, WI, United States
Products
AD-TECH Drill Sleeve Guides, used with Ad-Tech Placement Kits: (a) REF DSG-90-2.3N (b) REF DSG-6.3-090-2.4N
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2544-2019Don't want to check this manually?
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