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U.S. Department of Health and Human Services

Class 2 Device Recall Smith & Nephew ACUFEX TRUNAV Retrograde Drill 5.5MM

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  Class 2 Device Recall Smith & Nephew ACUFEX TRUNAV Retrograde Drill 5.5MM see related information
Date Initiated by Firm March 15, 2017
Create Date April 18, 2017
Recall Status1 Terminated 3 on July 10, 2018
Recall Number Z-1838-2017
Recall Event ID 76824
Product Classification Bit, surgical - Product Code GFG
Product Smith & Nephew ACUFEX TRUNAV Retrograde Drill 5.5MM
Product Number: 72204037
The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone
Code Information Batch Numbers: G11243 G11244 G18810 G18813 G32171 G32172
Recalling Firm/
Smith & Nephew, Inc.
130 & 120 Forbes Blvd
Mansfield MA 02048
For Additional Information Contact SAME
Manufacturer Reason
for Recall
Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
FDA Determined
Cause 2
Device Design
Action 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.
Distribution Worldwide Distribution - US (Nationwide) and Internationally to AU, CL, DB, DE, ES, FR, GB, NL, SE
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.