Smith & Nephew, Inc. recalls Smith & Nephew ACUFEX TRUNAV Retrograde Drill 8.5MM Product Number: 72204043 The ACUFEX TRUNAV Retrograde Drill is inte…

Recall date

March 15, 2017

Source

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

Recall number

Z-1844-2017

FDA classification

Class II

Brand / firm

Smith & Nephew, Inc.

Sold / distributed

Worldwide Distribution - US (Nationwide) and Internationally to AU, CL, DB, DE, ES, FR, GB, NL, SE

Why it was recalled

Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming

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

What was recalled

Smith & Nephew ACUFEX TRUNAV Retrograde Drill 8.5MM Product Number: 72204043 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone