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Recall Observatory FDA recall evidence

Device product

CORAIL COXA VARA HIGH OFFSET STEM Collared Size 9

Z-0593-2018

July 12, 2017

Class II

Product summary

Firm
DePuy Orthopaedics, Inc.
Event
Event 79024
Status
Terminated
Classification
Class II
Quantity
21 Units
Official record key
device-enforcement:Z-0593-2018

Official wording

Reason: 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).

Code information: Part No. 3L93709 and Lot No. 5291990

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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).