FDAClass IIFebruary 21, 2018

Corail High Offset Stem Collarless recall

CORAIL HIGH OFFSET STEM Collarless SIZE 14

Why was Corail High Offset Stem Collarless recalled?

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).

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Part No. L20314 and Lot No. 5292130

Product
CORAIL HIGH OFFSET STEM Collarless SIZE 14
Recalling firm
DePuy Orthopaedics, Inc.
Quantity
19
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.
Recall date
February 21, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls