RecallRadar

FDA Device recall Z-1845-2017

Smith & Nephew ACUFEX TRUNAV Retrograde Drill 9MM Product Number: 72204044 The ACUFEX TRUNAV Retrograde Drill is intended for use in creati…

On 2017-04-26 the FDA classified a Class II recall of Smith & Nephew ACUFEX TRUNAV Retrograde Drill 9MM Product Number: 72204044 The ACUFEX TRUNAV Retrograde Drill is intended for use in creati… by Smith And Nephew, citing potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1845-2017
ClassificationClass II
Statusterminated
Initiated2017-03-15
Published2017-04-26
Last updated2026-09-13 11:54 UTC
CompanySmith And Nephew
DistributionUS

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

Reason

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

Identifiers

code_info
Batch Numbers: F86213 ,F86216 , G04654, G04655, G04656, G10376 G10377, G11224, G11226, G11237, G11238, G15935, G1593…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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1845-2017%22

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