Medical Device Recall Search

Recall Search

Medical Device Recall Search

Search live FDA recall data for medical devices. Enter a device type, brand name, or body area. Results come directly from the FDA's device recall database, updated continuously.

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1831 results for “knee”

  • Journey BCS Knee CoCr Femoral Components, Catalog Numbers: 74021210, 74021211, 74021212, 74021213, 74021214, 74021215, 74021216, 74021217, 74021218, 74021219, 74021220, 74021221, 74021222, 74021223, …

    Recalling firm
    Smith & Nephew, Inc.
    Status
    Open, Classified
    Date initiated
    2018-06-13
    Reason for recall
    The data in the National Joint Registry of England, Wales and Northern Ireland (NJREWNI) and Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) indicate that the first generation JOURNEY BCS Knee System has a revision rate over 1.5 times the primary total knee arthroplasty device class average revision rates reported in those registries.

  • JOURNEY BCS OXINIUM Knee Femoral Components, Catalog Numbers: 74021110, 74021111, 74021112, 74021113, 74021114, 74021115, 74021116, 74021117, 74021118, 74021119, 74021120, 74021121, 74021122, 740211…

    Recalling firm
    Smith & Nephew, Inc.
    Status
    Open, Classified
    Date initiated
    2018-06-13
    Reason for recall
    The data in the National Joint Registry of England, Wales and Northern Ireland (NJREWNI) and Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) indicate that the first generation JOURNEY BCS Knee System has a revision rate over 1.5 times the primary total knee arthroplasty device class average revision rates reported in those registries.

  • Vanguard 360 Revision Knee System Knee prostheses

    Recalling firm
    Zimmer Biomet, Inc.
    Status
    Terminated
    Date initiated
    2016-08-08
    Reason for recall
    The drill bit used to drill the hex pre-drilled hole in the screw head of the Tibial Augment Bolts included in the Vanguard 360 Revision Knee System was larger than allowable per the process specification. As a result, the hex geometry can still be visible, but there are radial cuts into the hex flat. Therefore, when the bolt is inserted into the augment, the screwdriver is unable to catch on the hex geometry, or the screwdriver strips the remaining hex geometry, and the bolt is unable to be fully tightened.

    The bolt stripping or the bolt not being fully tightened will be noticed by the surgeon intraoperatively when he or she is unable to screw the augment bolts into the augment. This possible event can result in an intraoperative delay resulting in increased time under anesthesia.

  • JOURNEY BCS Knee Conventional Polyethylene Inserts: 74023111, 74023112, 74023113, 74023114, 74023115, 74023116, 74023117, 74023118, 74023121, 74023122, 74023123, 74023124, 74023125, 74023126, 740231…

    Recalling firm
    Smith & Nephew, Inc.
    Status
    Open, Classified
    Date initiated
    2018-06-13
    Reason for recall
    The data in the National Joint Registry of England, Wales and Northern Ireland (NJREWNI) and Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) indicate that the first generation JOURNEY BCS Knee System has a revision rate over 1.5 times the primary total knee arthroplasty device class average revision rates reported in those registries.

  • EPIK KNEE SYSTEM Angled Insert Impactor LM/RL; Catalog #801-03-051 Rev. A; non-sterile; knee prosthesis instrument. Distributed by Encore Medical, L.P., Austin, TX 78758.

    Recalling firm
    Encore Medical, Lp
    Status
    Terminated
    Date initiated
    2007-08-09
    Reason for recall
    Angled Insert Impactor may scratch Tibial Insert on the articulating surface, causing increased wear at the damaged site.

  • EPIK KNEE SYSTEM Angled Insert Impactor RM/LL; Part #801-03-052 Rev. A; non-sterile; knee prosthesis instrument. Distributed by Encore Medical, L.P., Austin, TX 78758.

    Recalling firm
    Encore Medical, Lp
    Status
    Terminated
    Date initiated
    2007-08-09
    Reason for recall
    Angled Insert Impactor may scratch Tibial Insert on the articulating surface, causing increased wear at the damaged site.

  • Duracon Total Knee Distal Femoral Locking Screw for 5 mm Spacer; Product No. 6632-5-600. Made in Ireland; Howmedica Osteonics; 325 Corporate Drive, Mahwah, NJ 07430 Intended for primary or seconda…

    Recalling firm
    Stryker Howmedica Osteonics Corp.
    Status
    Terminated
    Date initiated
    2006-10-05
    Reason for recall
    Stryker Orthopaedics became aware that a box labeled as Duracon Total Knee Distal Femoral Locking Screws for 5 mm spacer, may actually contain a 10 mm screw.

  • OPTETRAK Comprehensive Knee System, labeled as the following: a. OPTETRAK All-polyethylene CR Tibial Components, with Product Line Numbers: 200-11-XX, 200-12-XX, 200-13-XX, 200-14-XX, 200-15-XX, 20…

    Recalling firm
    Exactech, Inc.
    Status
    Open, Classified
    Date initiated
    2021-08-30
    Reason for recall
    Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.

  • OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall …

    Recalling firm
    Exactech, Inc.
    Status
    Open, Classified
    Date initiated
    2021-08-30
    Reason for recall
    Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.

  • OPTETRAK Comprehensive Knee System custom devices labeled as the following: a. CUSTOM OPTETRAK ANGLED PS INSERT (Product Line: 900-06-XX, 900-08-XX); b. CUSTOM OPTETRAK CC TIBIAL INSERT (Product …

    Recalling firm
    Exactech, Inc.
    Status
    Open, Classified
    Date initiated
    2021-08-30
    Reason for recall
    Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.