Z-1843-2017 Class II Terminated

Recalled by Smith & Nephew, Inc. — Mansfield, MA

Recall Details

Product Type
Devices
Report Date
April 26, 2017
Initiation Date
March 15, 2017
Termination Date
July 10, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
N/A

Product Description

Smith & Nephew ACUFEX TRUNAV Retrograde Drill 8MM Product Number: 72204042 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone

Reason for Recall

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

Distribution Pattern

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

Code Information

Batch Numbers: F92143, F92147, G10380, G10382, G11216, G11217 G11231, G11232, G15940, G15943, G18835, G18836, G30219 G30220, G30254, G30255, G32180, G32182, G32183, G32184