The Recall Desk
SevereFDA (Devices)·Z-1843-2017·Announced 2017-04-26

Smith & Nephew ACUFEX TRUNAV Retrograde Drill Recalled for Blade Detachment Risk

Smith & Nephew is recalling ACUFEX TRUNAV Retrograde Drills because the cutting blade may detach or the drill head may fracture during use.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect (blade detachment/fracture) in a surgical device, which meets the criteria for a Severe rating due to the potential for significant injury.

Plain-English summary

Smith & Nephew, Inc. is recalling the ACUFEX TRUNAV Retrograde Drill 8MM (Product Number 72204042). The device is intended for use in creating a back bore socket in bone. The recall covers specific batch numbers including F92143, F92147, G10380, G10382, G11216, G11217, G11231, G11232, G15940, G15943, G18835, G18836, G30219, G30220, G30254, G30255, G32180, G32182, G32183, and G32184.

The recall was initiated due to a potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming. This is a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

The affected products were distributed worldwide, including nationwide in the United States and internationally to Australia, Chile, Denmark, Germany, Spain, France, Great Britain, the Netherlands, and Sweden. Healthcare providers and facilities should stop using the affected devices and contact Smith & Nephew for further instructions.

The recalled product

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
Manufacturer
Smith & Nephew, Inc.
Category
Medical Device — Surgical Instrument
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (18)

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

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 14 recalled by Smith & Nephew, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 14 products in this recall →

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