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.
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 involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the High severity criteria for potential mechanical failure during surgery.
Plain-English summary
Smith & Nephew, Inc. is recalling the ACUFEX TRUNAV Retrograde Drill 10MM (Product Number: 72204046). 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 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. Specific batch numbers involved in the recall include F91770, F92141, G10378, G10379, G10788, G10790, G11229, G11230, G11235, G11236, G15938, G15939, G18830, G18832, G27835, G27836, G30217, G30218, G30250, G30251, and G32170.
Healthcare providers and facilities should stop using the affected devices and contact Smith & Nephew for instructions on return or replacement. The source text does not report any specific injuries or illnesses associated with this recall.
The recalled product
- Product
- Smith & Nephew ACUFEX TRUNAV Retrograde Drill 10MM Product Number: 72204046 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone
- Manufacturer
- Smith & Nephew, Inc.
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: F91770
- F92141
- G10378
- G10379
- G10788
- G10790 G11229
- G11230
- G11235
- G11236
- G15938
- G15939
- G18830
- G18832 G27835
- G27835
- G27836
- G30217
- G30218
- G30250
- G30251
- G32170
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.
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