FDA-Device2020-12-23Class II
DePuy Synthes 14.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.025S
Synthes (USA) Products LLC
Hazard
RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniques are not followed
Sold states
Nationwide Foreign:countries: United Arab Emirates, Austria, Australia, Belgium, Switzerland, China, Czech Republic, Germany, Spain, United Kingdom, Ireland, Israel, Italy, Singapore,
Affected count
1142 US; 450 OUS
Manufactured in
1301 Goshen Pkwy, N/A, West Chester, PA, United States
Products
DePuy Synthes 14.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.025S
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0580-2021Don't want to check this manually?
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