FDA-Device2023-07-05Class II
REF 1975.14.500, Prima TT Genoid Monoblock Reverse TT Baseplate, STERILE R
Limacorporate S.p.A
Hazard
Due to manufacturing issue, their is a potential for peripheral holes to be out of specification.
Sold states
US Nationwide distribution in the states of MI, IL, ND, MO, OK.
Affected count
13 units
Manufactured in
Via Nazionale 52, Di San Daniele, San Daniele Del Friuli, N/A, Italy
Products
REF 1975.14.500, Prima TT Genoid Monoblock Reverse TT Baseplate, STERILE R
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2009-2023Don't want to check this manually?
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