Z-0594-2018Class II

CORAIL HIGH OFFSET STEM Collarless SIZE 14

Name: Z-0594-2018 CORAIL HIGH OFFSET STEM Collarless SIZE 14
Creator: DePuy Orthopaedics, Inc.
Published: 2017-07-12
License: https://open.fda.gov/license/

Depuy Orthopaedics Inc. / initiated 2017-07-12 / Terminated / root cause: labeling and UDI

FDA source

DePuy Orthopaedics, Inc. began a recall of CORAIL HIGH OFFSET STEM Collarless SIZE 14 on 2017-07-12. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0594-2018
Classification: Class II
Status: Terminated
Initiated: 2017-07-12
Posted: 2018-02-12
Terminated: 2019-05-20
Recalling firm: Depuy Orthopaedics Inc.
Product: CORAIL HIGH OFFSET STEM Collarless SIZE 14
Product code: KWL Prosthesis, Hip, Hemi-, Femoral, Metal
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).
Root cause tag: labeling and UDI
FDA root cause: Mixed-up of materials/components
Action: In August of 2017 customers were notified via an Urgent Medical Device Recall Letter, titled "ONE LOT OF CORAIL COXA VARA HIGH OFFSET STEM Collared Size 9 and ONE LOT OF CORAIL HIGH OFFSET STEM Collarless SIZE 14" with instructions to cease using the affected product immediately. Note: The affected devices may be on consignment at your facility. Return Affected Implants: Determine if any of the recalled devices are still on hand and return the affected device(s) immediately to the DePuy Sales Consultant or return to DePuy Synthes for credit following the normal returns procedures. Reconciliation Form: Complete the Reconciliation Form and return to your DePuy Orthopaedics Sales Consultant or fax to 574-371-4939 or scan and email to [email protected] Records: Retain a copy of the completed Reconciliation Form in your files along with this notice. Additional Notifications: Notify surgeon users at your facility by providing them with a copy of this notice to ensure surgeon users are aware of this recall. Forward this notice to others in your facility that need to be informed. If any affected product has been forwarded to another facility, contact that facility immediately to communicate this field action with the facility/facilities. Maintain a copy of this notice with the affected devices. Contacts For product-related questions, please contact your local DePuy Orthopaedics, Inc. Sales Consultant. For clinical questions from surgeons, please contact DePuy Orthopaedics, Inc.s Scientific and Medical Affairs mailbox [email protected]. For questions about device recall information provided, please contact Kim (Earle) Long, Senior Recall Coordinator, at 574-371-4917 (M-F; 8 a.m. 5 p.m. EDT) or at [email protected]. Health care professionals may report serious adverse events, side effects or product quality problems with the use of this product to DePuy Orthopaedics, Inc. either by contacting yo
Quantity in commerce: 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.
Product codes and lots: Part No. L20314 and Lot No. 5292130

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0594-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0593-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-21	2018-02-12
Z-0594-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-21	2018-02-12

Product code KWL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)