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Smith & Nephew Recalls
258 recalls on record · September 26, 2012 to June 24, 2026 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
May 10, 2017Medical DevicesFDA
Smith & Nephew, Inc. recalls RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 10, REF 71369310, STERILE R, QTY: (1)
Hazard: The stability data does not support the product labeled with a 10-year shelf life.
April 26, 2017Medical DevicesFDA
Smith & Nephew, Inc. recalls D-RAD, S.T. LOCKING SCREWS, T7, QTY: (1), STERILE R, in the following sizes: (a) 2.4MM X 10MM, RES 74692410 (b) 2.4MM
Hazard: The expiration dates on the labeling are incorrect, the actual expiration dates are before the date on the labeling.
April 26, 2017Medical DevicesFDA
Smith & Nephew, Inc. recalls D-RAD, 2.4MMX 20MM, S.T. CORTEX SCREW, QTY: (1), STERILE R, RES 74682420 Orthopedic
Hazard: The expiration dates on the labeling are incorrect, the actual expiration dates are before the date on the labeling.
April 26, 2017Medical DevicesFDA
Smith & Nephew, Inc. recalls D-RAD, 1.8MM X 16MM, LOCKING PEG, QTY: (1), STERILE R, RES 74671816 Orthopedic
Hazard: The expiration dates on the labeling are incorrect, the actual expiration dates are before the date on the labeling.
April 26, 2017Medical DevicesFDA
Smith & Nephew, Inc. recalls Peri-Loc(R) VLP 3.5 MM X 6 MM SELF-TAPPING CORTEX SCREW, QTY: (1), STERILE R, REF 71801306 Orthopedic
Hazard: The expiration dates on the labeling are incorrect, the actual expiration dates are before the date on the labeling.
April 26, 2017Medical DevicesFDA
Smith & Nephew, Inc. recalls Smith & Nephew ACUFEX TRUNAV Retrograde Drill 12MM Product Number: 72204050 The ACUFEX TRUNAV Retrograde Drill is inte
Hazard: Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
April 26, 2017Medical DevicesFDA
Smith & Nephew, Inc. recalls Smith & Nephew ACUFEX TRUNAV Retrograde Drill 11.5MM Product Number: 72204049 The ACUFEX TRUNAV Retrograde Drill is in
Hazard: Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
April 26, 2017Medical DevicesFDA
Smith & Nephew, Inc. recalls Smith & Nephew ACUFEX TRUNAV Retrograde Drill 11MM Product Number: 72204048 The ACUFEX TRUNAV Retrograde Drill is inte
Hazard: Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
April 26, 2017Medical DevicesFDA
Smith & Nephew, Inc. recalls Smith & Nephew ACUFEX TRUNAV Retrograde Drill 10.5MM Product Number: 72204047 The ACUFEX TRUNAV Retrograde Drill is i
Hazard: Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
April 26, 2017Medical DevicesFDA
Smith & Nephew, Inc. recalls Smith & Nephew ACUFEX TRUNAV Retrograde Drill 10MM Product Number: 72204046 The ACUFEX TRUNAV Retrograde Drill is inte
Hazard: Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
April 26, 2017Medical DevicesFDA
Smith & Nephew, Inc. recalls Smith & Nephew ACUFEX TRUNAV Retrograde Drill 9.5MM Product Number: 72204045 The ACUFEX TRUNAV Retrograde Drill is int
Hazard: Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
April 26, 2017Medical DevicesFDA
Smith & Nephew, Inc. recalls Smith & Nephew ACUFEX TRUNAV Retrograde Drill 9MM Product Number: 72204044 The ACUFEX TRUNAV Retrograde Drill is inten
Hazard: Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
April 26, 2017Medical DevicesFDA
Smith & Nephew, Inc. recalls Smith & Nephew ACUFEX TRUNAV Retrograde Drill 8.5MM Product Number: 72204043 The ACUFEX TRUNAV Retrograde Drill is in
Hazard: Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
April 26, 2017Medical DevicesFDA
Smith & Nephew, Inc. recalls Smith & Nephew ACUFEX TRUNAV Retrograde Drill 8MM Product Number: 72204042 The ACUFEX TRUNAV Retrograde Drill is inte
Hazard: Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
April 26, 2017Medical DevicesFDA
Smith & Nephew, Inc. recalls Smith & Nephew ACUFEX TRUNAV Retrograde Drill 7.5MM Product Number: 72204041 The ACUFEX TRUNAV Retrograde Drill is int
Hazard: Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
April 26, 2017Medical DevicesFDA
Smith & Nephew, Inc. recalls Smith & Nephew ACUFEX TRUNAV Retrograde Drill 7MM Product Number: 72204040 The ACUFEX TRUNAV Retrograde Drill is inten
Hazard: Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
April 26, 2017Medical DevicesFDA
Smith & Nephew, Inc. recalls Smith & Nephew ACUFEX TRUNAV Retrograde Drill 6.5MM Product Number: 72204039 The ACUFEX TRUNAV Retrograde Drill is int
Hazard: Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
April 26, 2017Medical DevicesFDA
Smith & Nephew, Inc. recalls Smith & Nephew ACUFEX TRUNAV Retrograde Drill 6MM Product Number: 72204038 The ACUFEX TRUNAV Retrograde Drill is inten
Hazard: Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
April 26, 2017Medical DevicesFDA
Smith & Nephew, Inc. recalls Smith & Nephew ACUFEX TRUNAV Retrograde Drill 5.5MM Product Number: 72204037 The ACUFEX TRUNAV Retrograde Drill is int
Hazard: Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
March 1, 2017Medical DevicesFDA
Smith & Nephew, Inc. recalls Smith & Nephew Dyonics Saw Blade, Long, Special, Product Number 3706
Hazard: The single use devices are provided sterile and do not have an expiration date on the label.
March 1, 2017Medical DevicesFDA
Smith & Nephew, Inc. recalls Smith & Nephew Dyonics Saw Blade, Narrow, Product Number 3705
Hazard: The single use devices are provided sterile and do not have an expiration date on the label.
March 1, 2017Medical DevicesFDA
Smith & Nephew, Inc. recalls Smith & Nephew Dyonics Saw Blade, Short, Narrow, Product Number 3704
Hazard: The single use devices are provided sterile and do not have an expiration date on the label.
March 1, 2017Medical DevicesFDA
Smith & Nephew, Inc. recalls Smith & Nephew Dyonics Saw Blade, Short, Product Number 3703
Hazard: The single use devices are provided sterile and do not have an expiration date on the label.
March 1, 2017Medical DevicesFDA
Smith & Nephew, Inc. recalls Smith & Nephew Dyonics Saw Blade, Standard, Thick, Product Number 3702
Hazard: The single use devices are provided sterile and do not have an expiration date on the label.
March 1, 2017Medical DevicesFDA
Smith & Nephew, Inc. recalls Smith & Nephew Dyonics Saw Blade, Standard, Product Number 3701
Hazard: The single use devices are provided sterile and do not have an expiration date on the label.
January 25, 2017Medical DevicesFDA
Smith & Nephew, Inc. recalls Smith & Nephew, RENASYS GO Negative Pressure Wound Therapy External Power Supply Unit, Rx only. Intended for patient
Hazard: Lack of 510k clearance for design modification.
January 25, 2017Medical DevicesFDA
Smith & Nephew, Inc. recalls Smith & Nephew, RENASYS GO Negative Pressure Wound Therapy, Rx only. Intended for patients who would benefit from a
Hazard: Lack of 510k clearance for design modification.
January 18, 2017Medical DevicesFDA
Smith & Nephew, Inc. recalls REFLECTION(R) DEAD BLOW MALLET, REF 71362106, QTY: (1), NON-STERILE, Smith & Nephew, Inc,. Memphis, TN 38116
Hazard: The firm received complaints of cracks in the weld on the head of the mallet. In the reported cases, some of the lead beads and particles escaped from the mallet into the surgical wound.
January 11, 2017Medical DevicesFDA
Smith & Nephew, Inc. recalls Modular Necks: The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems are indicated for individuals undergoing primary
Hazard: All lots of modular neck hip prostheses are being recalled due to a higher than anticipated complaint and adverse event trend.
January 11, 2017Medical DevicesFDA
Smith & Nephew, Inc. recalls Modular SMF(TM) The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems are indicated for individuals undergoing primary
Hazard: All lots of modular neck hip prostheses are being recalled due to a higher than anticipated complaint and adverse event trend.