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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.
December 22, 2021Medical DevicesFDA
Smith & Nephew, Inc. recalls smith&nephew EVOS MEDIAL DISTAL FEMUR PLATE, R, 5H, 90MM, REF 72573201
Hazard: Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponents reports were erroneous. Erroneous data from the reports was incorporated in the released IFU 81110294 EVOS Large Fragment Plating System.
December 22, 2021Medical DevicesFDA
Smith & Nephew, Inc. recalls smith&Nephew EVOS MEDIAL DISTAL FEMUR PLATE, L, 5H, 90MM, REF 72573101
Hazard: Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponents reports were erroneous. Erroneous data from the reports was incorporated in the released IFU 81110294 EVOS Large Fragment Plating System.
November 24, 2021Medical DevicesFDA
Smith & Nephew, Inc. recalls Smith and Nephew EVOS Self-Tapping Locking Screw SST: (1)REF 72413575, 3.5MM x 75MM, and (2) REF 72413570, 3.5MM X 70MM
Hazard: The labels on the packages of screws were switched.
October 27, 2021Medical DevicesFDA
Smith & Nephew, Inc. recalls 6.5MMX165MM CANNULATED SCREW
Hazard: The product label incorrectly indicated that the screws are fully threaded, but the screws contained in the package were partially threaded.
June 30, 2021Medical DevicesFDA
Smith & Nephew, Inc. recalls LEGION Posterior Stabilized OXINIUM Femoral Component, REF 71421216, Size 6, Left, Nonporous Femoral Component, A/P 65.5
Hazard: The device components experienced a manufacturing process error that resulted in surface damage from product handling.
May 5, 2021Medical DevicesFDA
Smith & Nephew, Inc. recalls CANNU-Flex SILK Interference Screws 6 mmx 30 mm - Product Usage: used for interference fixation of bone-tendon-bone of s
Hazard: Mislabeled box contained a 6mm x 20mm screw instead of 6mm x 30mm screw
February 10, 2021Medical DevicesFDA
Smith & Nephew, Inc. recalls VERSABOND AB 40 GRAMS FORMULATION 2, antibiotic infused bone cement, Product Number: 71271440 - Product Usage: VERSABOND
Hazard: Potential heat and humidity exposure. The affected lot contained an atypical sandy, flaky or grainy consistency when mixing.
January 13, 2021Medical DevicesFDA
Smith & Nephew, Inc. recalls Bone fixation nail. TRIGEN INTERTAN - Product Usage: indicated for fractures of the femur including simple shaft fractur
Hazard: Manufacturing packaging error.
November 4, 2020Medical DevicesFDA
Smith & Nephew, Inc. recalls 5.5MM Arthrogarde Hip Access Cannula
Hazard: The J Lock feature on the cannula body was manufactured incorrectly, preventing the cannula from locking into an irrigation extender or arthroscope in the correct orientation.
October 28, 2020Medical DevicesFDA
Smith & Nephew, Inc. recalls MICRORAPTOR REGENESORB SUTURE ANCHOR- Absorbable Suture anchor Product Number: 72204984
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 MICRORAPTOR REGENESORB SUTURE ANCHOR- Absorbable Suture anchor Product Number: 72204983
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 HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BL- Absorbable Suture anchor Product Number: 72203801
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 HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BLK- Absorbable Suture anchor Product Number: 72203708
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 HEALICOIL RG SA 5.5MM W/3 UB-BL CB BL BK- Absorbable Suture anchor Product Number: 72203707
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 HEALICOIL RG SA 5.5MM W/2 UB-BL CBR BL-- Absorbable Suture anchor Product Number: 72203706
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 HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BK-- Absorbable Suture anchor Product Number: 72203705
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 HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL-- Absorbable Suture anchor Product Number: 72203704
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 HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL- Absorbable Suture anchor Product Number: 72203697
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 CRVD 2.3 SA UB COBRD BLACK- Absorbable Suture anchor Product Number: 72203291
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 CRVD 2.3 SA UB COBRD BLUE- Absorbable Suture anchor Product Number: 72203290
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 ULTRA HA 6.5 W/2 UB (BLUE & BLK)- Absorbable Suture anchor Product Number: 72202631
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 ULTRA HA 5.5 W/2 UB BLUE & BLK- Absorbable Suture anchor Product Number: 72202626
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 ULTRA HA 4.5 W/2 UB BLUE & BLK- Absorbable Suture anchor Product Number: 72202624
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 ULTRA PLLA HA 6.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202620
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 ULTRA PLLA HA 5.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202616
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 ULTRA PLLA HA 4.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202612
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 ULTRA PLLA/HA 6.5 W/3 UB- Absorbable Suture anchor Product Number: 72202610
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 ULTRA 6.5MM PLLA/HA 2 UBWHT/BL-Absorbable Suture anchor Product Number: 72202608
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 ULTRA PLLA/HA 5.5 W/3 UB-Absorbable Suture anchor Product Number: 72202603
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 ULTRA 5.5MM PLLA/HA 2 UBWHT/BL--Absorbable Suture anchor Product Number: 72202602
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