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Terminated

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

FDA Recall Z-1843-2017 · Posted None

Recalling FirmSmith & Nephew, Inc.
Recall StatusTerminated
Product CodeGFG
Date Initiated2017-03-15
Date Terminated2018-07-10

Reason for Recall

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

Firm 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 [email protected]. For questions regarding this recall call 508-261-3600.

Root Cause

Device Design

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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