FDA-Device2016-01-13Class II
SYNTHES; 13.5MM Medullary Reamer Head; 352.135 NON STERILE. Part of the Flexible Reamer Set for orthopedic surgical procedures.
Synthes (USA) Products LLC
Hazard
The 13.5mm Medullary Reamer head, lot #F-17180, is etched as dimension 13.5mm while the actual dimension is 14mm.
Sold states
US nationwide distibution.
Affected count
65
Manufactured in
1301 Goshen Pkwy, N/A, West Chester, PA, United States
Products
SYNTHES; 13.5MM Medullary Reamer Head; 352.135 NON STERILE. Part of the Flexible Reamer Set for orthopedic surgical procedures.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0585-2016Don't want to check this manually?
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