FDA-Device2018-02-21Class II
CORAIL HIGH OFFSET STEM Collarless SIZE 14
DePuy Orthopaedics, Inc.
Hazard
Incorrect device in the package. A package that was labeled as the CORAIL COXA VARA HIGH OFFSET STEM Collared Size 9 (Part No. 3L93709 / Lot No. 5291990), contained the CORAIL HIGH OFFSET STEM Collarless SIZE 14 (Part No. L20314 / Lot No. 5292130).
Sold states
Nationally; US Consignees for this recall are the affected are US Distributors and US Medical Facilities (Hospitals/User Facilities) that may have purchased, used, or received the affected device.
Affected count
19
Manufactured in
700 Orthopaedic Dr, Warsaw, IN, United States
Products
CORAIL HIGH OFFSET STEM Collarless SIZE 14
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0594-2018Don't want to check this manually?
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