FDA-Device2017-09-06Class II
MODIFIED/SPECIAL INSTRUMENT, TURON GLENOID REAMER, REAM AND RUN, Catalog Numbers: REF S-200956 - 5mm PIN, SIZE 46 REF S-200957 - 5mm PIN, SIZE 50 REF S-200958 - 5mm PIN, SIZE 58
Encore Medical, Lp
Hazard
It was reported that the models used to manufacture S-200956/958 had the wrong dimension used to create the spherical radius cutting surface. Device design allows a larger spherical radius cutting surface than intended.
Sold states
OH, VA
Affected count
5 units
Manufactured in
9800 Metric Blvd, N/A, Austin, TX, United States
Products
MODIFIED/SPECIAL INSTRUMENT, TURON GLENOID REAMER, REAM AND RUN, Catalog Numbers: REF S-200956 - 5mm PIN, SIZE 46 REF S-200957 - 5mm PIN, SIZE 50 REF S-200958 - 5mm PIN, SIZE 58
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3102-2017Don't want to check this manually?
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