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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.
October 28, 2020Medical DevicesFDA
Smith & Nephew, Inc. recalls OSTEORAPTOR 2.9 W 1UB II BLUE--Absorbable Suture anchor Product Number: 72202165
Hazard: Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
October 28, 2020Medical DevicesFDA
Smith & Nephew, Inc. recalls OSTEORAPTOR 2.9 W. 2 UB WHITE / BLACK -Absorbable Suture anchor Product Number: 72201996
Hazard: Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
October 28, 2020Medical DevicesFDA
Smith & Nephew, Inc. recalls OSTEORAPTOR 2.9 W/ 2 UB WHITE / BLUE -Absorbable Suture anchor Product Number: 72201995
Hazard: Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
October 28, 2020Medical DevicesFDA
Smith & Nephew, Inc. recalls OSTEORAPTOR 2.9 W/ 1 UB COBRAID BLUE -Absorbable Suture anchor Product Number: 72201994
Hazard: Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
October 28, 2020Medical DevicesFDA
Smith & Nephew, Inc. recalls OSTEORAPTOR 2.3 W. UB COBRAID BLUE-Absorbable Suture anchor Product Number: 72201993
Hazard: Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
October 28, 2020Medical DevicesFDA
Smith & Nephew, Inc. recalls OSTEORAPTOR 2.3 W/ 1 UB COBRAID BLACK-Absorbable Suture anchor Product Number: 72201992
Hazard: Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
October 28, 2020Medical DevicesFDA
Smith & Nephew, Inc. recalls OSTEORAPTOR 2.3 W 1UB II BLUE-Absorbable Suture anchor Product Number: 72201991
Hazard: Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
October 28, 2020Medical DevicesFDA
Smith & Nephew, Inc. recalls RAPTORMITE 3.7MM AB W/ NEEDLES AND TWO-Absorbable Suture anchor Product Number: 72201805
Hazard: Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
October 28, 2020Medical DevicesFDA
Smith & Nephew, Inc. recalls BIORAPTOR 2.9MM SUTURE ANCHOR-Absorbable Suture anchor Product Number: 72201702
Hazard: Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
October 28, 2020Medical DevicesFDA
Smith & Nephew, Inc. recalls ULTRA FAST-FIX AB ASSEMBLY-REVERSE CURVE-Absorbable Suture anchor Product Number: 72201495
Hazard: Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
October 28, 2020Medical DevicesFDA
Smith & Nephew, Inc. recalls ULTRA FAST-FIX AB ASSEMBLY - CURVED-Absorbable Suture anchors Product Number: 72201494
Hazard: Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
October 28, 2020Medical DevicesFDA
Smith & Nephew, Inc. recalls ULTRA FAST-FIX AB ASSEMBLY - STRAIGHT-Absorbable Suture anchors Product Number: 72201493
Hazard: Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
October 28, 2020Medical DevicesFDA
Smith & Nephew, Inc. recalls TWINFIX AB 5.0 SUTR ANCHR W/2 38 DURAB-Absorbable Suture anchors Product Number: 72200785
Hazard: Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
October 28, 2020Medical DevicesFDA
Smith & Nephew, Inc. recalls TWINFIX AB 5.0 SUTR ANCHR W/2 38 ULTRA-Absorbable Suture anchors Product Number:72200777
Hazard: Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
October 28, 2020Medical DevicesFDA
Smith & Nephew, Inc. recalls TWINFIX 6.5MM AB PRELOADED SUTURE ANCHOR- Absorbable Suture anchors Product Number: 7210713
Hazard: Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
October 28, 2020Medical DevicesFDA
Smith & Nephew, Inc. recalls TWINFIX 6.5MM AB PRELOADED ULTRABRAID- Absorbable Suture anchors Product Number: 7210712
Hazard: Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
October 28, 2020Medical DevicesFDA
Smith & Nephew, Inc. recalls TWINFIX 5.0MM AB SUTURE ANCHOR-Absorbable Suture anchors Product Number: 7210711
Hazard: Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
October 28, 2020Medical DevicesFDA
Smith & Nephew, Inc. recalls TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO- Absorbable Suture anchors Product Number: 7210710
Hazard: Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
October 28, 2020Medical DevicesFDA
Smith & Nephew, Inc. recalls TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO Absorbable Suture anchors Product Number: 7210309
Hazard: Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
October 28, 2020Medical DevicesFDA
Smith & Nephew, Inc. recalls Genesis (GII) - Product Usage: designed for use in patients in primary and revision surgery, where the posterior cruciat
Hazard: The anterior locking detail does not meet its design specifications.
September 16, 2020Medical DevicesFDA
Smith & Nephew, Inc. recalls EVOS Screws - Product Usage: is a part of the EVOS MINI plating system, indicated for fracture fixation, arthrodesis, re
Hazard: Multiple or incorrect expiration dates were provided on the affected designation labels.
August 26, 2020Medical DevicesFDA
Smith & Nephew, Inc. recalls Single RIKKI Retractor, Catalog #71934609 - Product Usage: is used during surgery to hold soft tissue away from the surg
Hazard: The products were improperly heat treated.
August 19, 2020Medical DevicesFDA
Smith & Nephew, Inc. recalls PERI-LOC TARGETER 4.5MM DISTAL FEMUR, HANDLE, LEFT, NON-STERILE - Product Usage: used for adult and pediatric patients,
Hazard: The 4.5MM PeriLoc Targeter right hand part was anodized green and was marked as a left-hand part.
August 19, 2020Medical DevicesFDA
Smith & Nephew, Inc. recalls Tibial knee prosthesis
Hazard: Due to an inconsistency in the raw material process, specific lots may contain units with internal non-homogenous material defects.
August 12, 2020Medical DevicesFDA
Smith & Nephew, Inc. recalls SUTUREFIX ULTRA Suture, Product number 72203855
Hazard: A packaging error resulted in a XL drill being presented for use instead of the S drill. The XL drill is one inch longer than the S drill.
August 5, 2020Medical DevicesFDA
Smith & Nephew, Inc. recalls Smith & Nephew T-F1X0 RCG Drill Pac, 2 mm Drill & (2) Sleeves - Product Usage: indicated for use in surgical arthroscopi
Hazard: The T-Fix sterile package contains only one sleeve instead of two, The device will not perform as intended for the second bone tunnel due to the absence of thesleeve
July 29, 2020Medical DevicesFDA
Smith & Nephew, Inc. recalls TRIGEN, Intramedullary nail - Product Usage: is intended to provide resistance for screw back-out. It provides additiona
Hazard: A manufacturing error which resulted in the re-sterilization of the ultra-high-molecular-weight polyethylene (UHMWPE) sleeve.
June 17, 2020Medical DevicesFDA
Smith & Nephew, Inc. recalls smith&nephew R3 MULTI HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF
Hazard: A manufacturing error resulted in out of specification R3 Acetabular Shells
June 17, 2020Medical DevicesFDA
Smith & Nephew, Inc. recalls smith&nephew R3 MULTI HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Sizes REF/product
Hazard: A manufacturing error resulted in out of specification R3 Acetabular Shells
June 17, 2020Medical DevicesFDA
Smith & Nephew, Inc. recalls smith&nephew R3 THREE HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF
Hazard: A manufacturing error resulted in out of specification R3 Acetabular Shells