Recall Z-0594-2018— DePuy Orthopaedics, Inc.

Name: FDA recall Z-0594-2018
Creator: U.S. Food and Drug Administration
Published: 2017-07-12

Class II · Terminated

Class II FDA medical device recall by DePuy Orthopaedics, Inc., initiated 2017-07-12, terminated 2019-05-20. FDA's recall record names no specific 510(k) clearance for this event. Product: CORAIL HIGH OFFSET STEM Collarless SIZE 14. 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)..

Recalling firm: DePuy Orthopaedics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-07-12
Terminated: 2019-05-20
Firm location: Warsaw, IN, United States

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).

Data sourced from openFDA. This site is unofficial and independent of the FDA.