—#164940

Product

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

FDA product code: KWL — Prosthesis, Hip, Hemi-, Femoral, Metal
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K042992, K123991
Affected lot / code info: 5307603 5300997

Why it was recalled

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 (FDA determination)

Process control

Action the firm took

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 klong16@its.jnj.com. U.S. Distributors and Sales Offices received a separate notice with specific instructions on how to identify, remove, and return the affected devices.

Recalling firm

Firm: DePuy Orthopaedics, Inc.
Address: 700 Orthopaedic Dr, Warsaw, Indiana 46582-3994

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2018-06-21
Terminated: 2020-04-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #164940. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.