The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1845-2017·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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Smith & Nephew, Inc. is recalling the ACUFEX TRUNAV Retrograde Drill 9MM (Product Number: 72204044). This medical device is intended for use in creating a back bore socket in bone. The recall covers specific batch numbers, including 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, and G32177.

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 defect poses a risk of injury to patients or damage to the surgical site if the device fails during the procedure.

The affected devices 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 further instructions on return or replacement.

The recalled product

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
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 (20)

  • Batch Numbers: F86213
  • F86216
  • G04654
  • G04655
  • G04656
  • G10376 G10377
  • G11224
  • G11226
  • G11237
  • G11238
  • G15935
  • G15936
  • G15937
  • G18822
  • G18823
  • G18824
  • G18826
  • G18837
  • G18838
  • G18840

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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