FDA-Device2016-09-07Class II

SMR allen wrench 5 mm, product code 9013.50.210

Limacorporate S.p.A
Hazard

Product found to be dimensionally non-conforming (slightly over dimensioned on the diameter of the Zimmer connection) and non-functional for connecting with some T-handles.

Sold states
US, Italy, Australia
Affected count
76
Manufactured in
Via Nazionale 52, N/A, San Daniele Del Friuli, N/A, Italy
Products
SMR allen wrench 5 mm, product code 9013.50.210

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2707-2016

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