FDA recall Z-2009-2023

Limacorporate S.p.A · Class II · device

Product

REF 1975.14.500, Prima TT Genoid Monoblock Reverse TT Baseplate, STERILE R

Reason for recall

Due to manufacturing issue, their is a potential for peripheral holes to be out of specification.

Distribution

US Nationwide distribution in the states of MI, IL, ND, MO, OK.

Key facts

Status
Ongoing
Initiation date
2023-05-30
Report date
2023-07-05
Voluntary/Mandated
Voluntary: Firm initiated
Location
San Daniele Del Friuli, N/A, Italy

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2009-2023