Smith & Nephew ACUFEX TRUNAV Retrograde Drill 7MM Product Number: 72204040 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone
- Company
- Smith & Nephew, Inc.
- Recall Initiated
- March 15, 2017
- Terminated
- July 10, 2018
- Recall Number
- Z-1841-2017
- Firm Location
- Mansfield, MA
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
Worldwide Distribution - US (Nationwide) and Internationally to AU, CL, DB, DE, ES, FR, GB, NL, SE
Lot / Code Info
Batch Numbers: F93290, F93297, G10709, G10712, G15944, G15945, G27849
Root Cause
Device Design
Action Taken
Smith &n Nephew sent an Urgent Medical Device Recall Notice dated March 15, 2017, to all affected customers via Federal Express. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return product and to follow instructions on the attached Response Form. Customers with questions were instructed to email FieldActions@smith-nephew.com. For questions regarding this recall call 508-261-3600.