FDA (Devices) recall action 76824

Smith & Nephew, Inc. recalled 14 products on 2017-04-26

The FDA (Devices) publishes a recall like this one as 14 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 14 pages.

Products: 14
Announced: 2017-04-26
Critical: 0
Units: —

Why these products were recalled

Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming

The agency’s own wording, quoted from the enforcement report.

1–14 of 14

SevereFDA (Devices)··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.
Product
Smith & Nephew ACUFEX TRUNAV Retrograde Drill 8.5MM Product Number: 72204043 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone
Category
Distribution
0 states
SevereFDA (Devices)··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.
Product
Smith & Nephew ACUFEX TRUNAV Retrograde Drill 10.5MM Product Number: 72204047 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone
Category
Distribution
0 states
HighFDA (Devices)··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.
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
Category
Distribution
0 states
SevereFDA (Devices)··2017-04-26
Smith & Nephew ACUFEX TRUNAV Retrograde Drill Recall for Blade Detachment
Smith & Nephew is recalling ACUFEX TRUNAV Retrograde Drills because the cutting blade may detach or the drill head may fracture during use.
Product
Smith & Nephew ACUFEX TRUNAV Retrograde Drill 6.5MM Product Number: 72204039 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone
Category
Distribution
0 states
SevereFDA (Devices)··2017-04-26
Smith & Nephew ACUFEX TRUNAV Retrograde Drill Recalled for Blade Detachment Risk
Smith & Nephew is recalling ACUFEX TRUNAV Retrograde Drills due to a potential for the cutting blade to detach or the drill head to fracture during use.
Product
Smith & Nephew ACUFEX TRUNAV Retrograde Drill 7.5MM Product Number: 72204041 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone
Category
Distribution
0 states
SevereFDA (Devices)··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.
Product
Smith & Nephew ACUFEX TRUNAV Retrograde Drill 5.5MM Product Number: 72204037 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone
Category
Distribution
0 states
SevereFDA (Devices)··2017-04-26
Smith & Nephew ACUFEX TRUNAV Retrograde Drill Recall for Blade Detachment Risk
Smith & Nephew is recalling ACUFEX TRUNAV Retrograde Drills due to a potential for the cutting blade to detach or the drill head to fracture during use.
Product
Smith & Nephew ACUFEX TRUNAV Retrograde Drill 7MM Product Number: 72204040 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone
Category
Distribution
0 states
SevereFDA (Devices)··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.
Product
Smith & Nephew ACUFEX TRUNAV Retrograde Drill 12MM Product Number: 72204050 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone
Category
Distribution
0 states
HighFDA (Devices)··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.
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
Category
Distribution
0 states
SevereFDA (Devices)··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.
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
Category
Distribution
0 states
HighFDA (Devices)··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.
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
Category
Distribution
0 states
SevereFDA (Devices)··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.
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
Category
Distribution
0 states
SevereFDA (Devices)··2017-04-26
Smith & Nephew ACUFEX TRUNAV Retrograde Drill Recall for Blade Detachment
Smith & Nephew is recalling ACUFEX TRUNAV Retrograde Drills because the cutting blade may detach or the drill head may fracture during use.
Product
Smith & Nephew ACUFEX TRUNAV Retrograde Drill 6MM Product Number: 72204038 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone
Category
Distribution
0 states
SevereFDA (Devices)··2017-04-26
Smith & Nephew ACUFEX TRUNAV Retrograde Drill Recall for Blade Detachment
Smith & Nephew is recalling ACUFEX TRUNAV Retrograde Drills because the cutting blade may detach or the drill head may fracture during use.
Product
Smith & Nephew ACUFEX TRUNAV Retrograde Drill 11.5MM Product Number: 72204049 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone
Category
Distribution
0 states