DePuy Orthopaedics, Inc. recalls CORAIL Cementless Femoral Stem HA Coated Standard Size 11, Catalog No. 3L92511

Recall date

June 21, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2521-2018

FDA classification

Class II

Brand / firm

DePuy Orthopaedics, Inc.

Sold / distributed

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.

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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