BEUDAMED
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    SambaScrew 3D SI Fusion System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517639066·CoRoent Ant TLIF PEEK, 8x13x34mm 12°

    3.0T METAFLEXCOIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    ORBITAL RECONSTRUCTIVE IMPLANT II

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    OSSURE LOEP KIT

    FDA Adverse Event
    Death ·AGNOVOS HEALTHCARE USA, LLC·Product code MQV·December 27, 2018

    OSSURE LOEP KIT

    FDA Adverse Event
    Death ·AGNOVOS HEALTHCARE USA, LLC·Product code MQV·January 18, 2020

    PRECISION®

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 18, 2014

    DEPUY ASR XL FEM IMP SIZE 46

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. - 8010379·Product code KXA·June 21, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 28, 2011

    BD DISCARDIT¿ 2-PIECE SYRINGE WITH BD MICROLANCE¿ NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·December 21, 2017

    Sof-Flex Double Pigtail Ureteral Stent Set, Global Product No. G15076 G14906 G14840 G14865 G17128

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·February 12, 2020

    THREE PEG PATELLA 41MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·December 26, 2025

    OPTETRAK

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·July 1, 2024

    OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. OPTETRAK Logic PSC Tibial Inserts, Product Line 02-012-44-XXXX; c. OPTETRAK Logic CR Tibial Inserts, Product Line 02-012-47-XXXX; d. OPTETRAK Logic CR Slope + Tibial Inserts, Product Line 02-012-48-XXXX; e. OPTETRAK Logic CR Slope ++ Tibial Inserts, Product Line 02-012-49-XXXX; f. OPTETRAK Logic CRC Tibial Inserts, Product Line 02-012-51-XXXX; g. OPTETRAK Logic CC Tibial Inserts, Product Line 02-012-65-XXXX; Affected 510(k) numbers include: K033883, K132161, K093360, K110547, K111400, K121307, K123342, K150890. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Recall
    Open, Classified ·Exactech, Inc.·Product code JWH·August 30, 2021

    OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. OPTETRAK Logic PSC Tibial Inserts, Product Line 02-012-44-XXXX; c. OPTETRAK Logic CR Tibial Inserts, Product Line 02-012-47-XXXX; d. OPTETRAK Logic CR Slope + Tibial Inserts, Product Line 02-012-48-XXXX; e. OPTETRAK Logic CR Slope ++ Tibial Inserts, Product Line 02-012-49-XXXX; f. OPTETRAK Logic CRC Tibial Inserts, Product Line 02-012-51-XXXX; g. OPTETRAK Logic CC Tibial Inserts, Product Line 02-012-65-XXXX; Affected 510(k) numbers include: K033883, K132161, K093360, K110547, K111400, K121307, K123342, K150890. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012