medical Class II Updated 2018-08-01

DePuy Orthopaedics, Inc. recalls CORAIL Cementless Femoral Stem HA Coated Standard Size 11, C

Recalled Product

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

Hazard / Issue

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.

Issued by

FDA

Affected States: AL, CA, CO, GA, IL, LA, ME, NC, NH, NY, OR, TX, UT, WA
Lot/Code Info: 5307603 5300997
View official government recall

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