FDA-Device2020-07-29Class II
TRIGEN, Intramedullary nail - Product Usage: is intended to provide resistance for screw back-out. It provides additional friction to help hold the screws in place.
Smith & Nephew, Inc.
Hazard
A manufacturing error which resulted in the re-sterilization of the ultra-high-molecular-weight polyethylene (UHMWPE) sleeve.
Sold states
International distribution in the countries of Brazil, Colombia and United Arab Emirates.
Affected count
12 units
Manufactured in
1450 E Brooks Rd, N/A, Memphis, TN, United States
Products
TRIGEN, Intramedullary nail - Product Usage: is intended to provide resistance for screw back-out. It provides additional friction to help hold the screws in place.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2685-2020Don't want to check this manually?
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