The Recall Desk
HighFDA (Devices)·Z-1849-2017·Announced 2017-04-26

Smith & Nephew ACUFEX TRUNAV Retrograde Drill Recall 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

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk of physical injury (blade detachment/fracture) during a surgical procedure, but no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Smith & Nephew, Inc. is recalling the ACUFEX TRUNAV Retrograde Drill 11MM (Product Number: 72204048). The device is intended for use in creating a back bore socket in bone. The recall covers specific batch numbers: G15888, G15934, and G18833.

The recall is being issued 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 classified as an FDA Class II recall.

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

The recalled product

Product
Smith & Nephew ACUFEX TRUNAV Retrograde Drill 11MM Product Number: 72204048 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone
Manufacturer
Smith & Nephew, Inc.
Category
Medical Device — Orthopedic 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 (3)

  • Batch Numbers: G15888
  • G15934
  • G18833

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 →

Related recalls

Same manufacturer · Smith & Nephew, Inc.

See all →

Same hazard · blade detachment

See all →