FDA recall Z-0593-2018

DePuy Orthopaedics, Inc. · Class II · device

Product

CORAIL COXA VARA HIGH OFFSET STEM Collared Size 9

Reason for recall

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).

Distribution

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.

Key facts

Status: Terminated
Initiation date: 2017-07-12
Report date: 2018-02-21
Termination date: 2019-05-20
Voluntary/Mandated: Voluntary: Firm initiated
Location: Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0593-2018