Z-1845-2017 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 9MM Product Number: 72204044 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: F86213 ,F86216 , G04654, G04655, G04656, G10376 G10377, G11224, G11226, G11237, G11238, G15935, G15936, G15937, G18822, G18823, G18824, G18826, G18837, G18838, G18840, G18841, G30215, G30216, G30247, G30248, G30256, G32169, G32173, G32174 G32175, G32176, G32177