PlainRecalls
FDA Devices Moderate Class II Terminated

CORAIL HIGH OFFSET STEM Collarless SIZE 14

Reported: February 21, 2018 Initiated: July 12, 2017 #Z-0594-2018

Product Description

CORAIL HIGH OFFSET STEM Collarless SIZE 14

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).

Details

Recalling Firm
DePuy Orthopaedics, Inc.
Units Affected
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.
Location
Warsaw, IN

Frequently Asked Questions

What product was recalled?
CORAIL HIGH OFFSET STEM Collarless SIZE 14. Recalled by DePuy Orthopaedics, Inc.. Units affected: 19.
Why was this product 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).
Which agency issued this recall?
This recall was issued by the FDA Devices on February 21, 2018. Severity: Moderate. Recall number: Z-0594-2018.