Z-1847-2017 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 10MM Product Number: 72204046 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: F91770, F92141, G10378, G10379, G10788, G10790 G11229, G11230, G11235, G11236, G15938, G15939, G18830, G18832 G27835, G27835, G27836, G30217, G30218, G30250, G30251, G32170