FDA-Device2018-08-01Class II
CORAIL Cementless Femoral Stem HA Coated Standard Size 11, Catalog No. 3L92511
DePuy Orthopaedics, Inc.
Hazard
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.
Sold states
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.
Affected count
N/A
Manufactured in
700 Orthopaedic Dr, N/A, Warsaw, IN, United States
Products
CORAIL Cementless Femoral Stem HA Coated Standard Size 11, Catalog No. 3L92511
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2521-2018Don't want to check this manually?
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