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FDAJune 21, 2018device

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

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Terminated

Brands named

depuy orthopaedicsdepuy

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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CORAIL Cementless Femoral Stem HA Coated Standard Size 11, Catalog No. 3L92511 — Recall Details · AllClear