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Recall Observatory FDA recall evidence

Device product

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

Z-1845-2017

March 15, 2017

Class II

Product summary

Firm
Smith & Nephew, Inc.
Event
Event 76824
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-1845-2017

Official wording

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

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

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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