Z-2521-2018Class II

CORAIL Cementless Femoral Stem HA Coated Standard Size 11, Catalog No. 3L92511

Name: Z-2521-2018 CORAIL Cementless Femoral Stem HA Coated Standard Size 11, Catalog No. 3L92511
Creator: DePuy Orthopaedics, Inc.
Published: 2018-06-21
License: https://open.fda.gov/license/

Depuy Orthopaedics Inc. / initiated 2018-06-21 / Terminated / root cause: manufacturing process

FDA source

DePuy Orthopaedics, Inc. began a recall of CORAIL Cementless Femoral Stem HA Coated Standard Size 11, Catalog No. 3L92511 on 2018-06-21. FDA classified it as Class II and gives the reason as "Two lots of femoral stems were labeled as Size 11. However, they are actually Size 12. Potential adverse effects include poor joint mechanics, improper fit, loosening, and additional surgical procedure to correct. It...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2521-2018
Classification: Class II
Status: Terminated
Initiated: 2018-06-21
Posted: 2018-10-11
Terminated: 2020-04-06
Recalling firm: Depuy Orthopaedics Inc.
Product: CORAIL Cementless Femoral Stem HA Coated Standard Size 11, Catalog No. 3L92511
Product code: KWL Prosthesis, Hip, Hemi-, Femoral, Metal
Reason for recall: Two lots of femoral stems were labeled as Size 11. However, they are actually Size 12. Potential adverse effects include poor joint mechanics, improper fit, loosening, and additional surgical procedure to correct. It may also result in an intraoperative fracture which could represent a surgical delay and additional procedures.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On June 21, 2018, the firm issued an Urgent Information: US Recall Notice via email to affected customers. Medical professionals were asked to do the following: " Cease using the affected components immediately. " Immediately return unused affected units: Medical facilities are to determine if any of the recalled components are still on hand, and return affected devices immediately to their DePuy Sales Consultant or return them to DePuy for credit following normal purchasing procedures. Reconciliation forms should be faxed to 574-371-4939. " Reconciliation Form: Complete the Reconciliation Form and return to your DePuy Synthes Sales Consultant or fax to 574-371-4939 within five (5) days of this notice. " 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 notice. Forward this notice to others in your facility that need to be informed. " Maintain a copy of this notice with the affected devices. For questions about device recall information provided, please contact Kim Long, Senior Recall Coordinator, at 574-371-4917 or [email protected]. U.S. Distributors and Sales Offices received a separate notice with specific instructions on how to identify, remove, and return the affected devices.
Distribution: Accounts in AL, CA, CO, GA< IL, LA, ME, NC, NH, NY, OR, TX, UT, and WA. Foreign distribution to Belgium, Croatia, Cyprus, Denmark, Germany, Indonesia, Korea, Sweden, and Tunisia.
Product codes and lots: 5307603 5300997

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2521-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2521-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-01	2018-07-20

Product code KWL

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)