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Recall Observatory FDA recall evidence

Device product

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

Z-1843-2017

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-1843-2017

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: F92143, F92147, G10380, G10382, G11216, G11217 G11231, G11232, G15940, G15943, G18835, G18836, G30219 G30220, G30254, G30255, G32180, G32182, G32183, G32184

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