Agency classClass IIOur severity:Severe FDA (Devices)·Z-1846-2017·Announced 2017-04-26

Smith & Nephew ACUFEX TRUNAV Retrograde Drill Recall for 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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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 the hazard involves a structural defect (fracture/detachment) of a surgical instrument used in bone, which poses a significant risk of injury.

Plain-English summary

Smith & Nephew, Inc. is recalling the ACUFEX TRUNAV Retrograde Drill 9.5MM (Product Number: 72204045). The device is intended for use in creating a back bore socket in bone. The recall is due to a potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming.

The affected batch numbers are F93298, F93299, F93300, G11240, G11242, G30252, and G30253. The product was distributed 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 9.5MM Product Number: 72204045 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: structural-failure
injury

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 (7)

Batch Numbers: F93298
F93299
F93300
G11240
G11242
G30252
G30253

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 →

Same manufacturer · Smith & Nephew, Inc.

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