Recall Z-2707-2016— Limacorporate S.p.A

Class II · Terminated

Class II FDA medical device recall by Limacorporate S.p.A, initiated 2016-07-21, terminated 2017-01-13. FDA's recall record names no specific 510(k) clearance for this event. Product: SMR allen wrench 5 mm, product code 9013.50.210. Reason: 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..

Recalling firm
Limacorporate S.p.A
Classification
Class II
Status
Terminated
Initiated
2016-07-21
Terminated
2017-01-13
Firm location
San Daniele Del Friuli, N/A, Italy

Product description

SMR allen wrench 5 mm, product code 9013.50.210

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.