BEUDAMED
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    Exactech Optetrak Logic CC

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OPTETRAK LOGIC

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·March 27, 2023

    LOGIC KNEE COMPONENTS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·March 13, 2023

    TRU CC TIB INSERT SIZE 5, 15MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·February 24, 2025

    LOGIC CC FEMORAL SIZE 4, RIGHT

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·April 12, 2023

    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

    Oticon

    FDA UDI
    Oticon A/S·05707131283900·RIA2, MINIBTE 312 WL 85 DBL

    SunMed

    FDA UDI
    SUNMED, LLC·20889483000905·CC BERMAN AIRWAYS 90mm PK/10

    VARIAN HIGH ENERGY LINEAR ACCELERATOR

    FDA 510(k)
    FDA Class 2 ·Radiology

    ECC.O SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BIOMET BONE CEMENT R 40X2

    FDA Adverse Event
    Malfunction ·BIOMET FRANCE S.A.R.L.·Product code MBB·November 9, 2016

    BIOMET BONE CEMENT V

    FDA Adverse Event
    Injury ·BIOMET FRANCE S.A.R.L.·Product code MBB·December 1, 2016

    BIOMET BONE CEMENT V

    FDA Adverse Event
    Injury ·BIOMET FRANCE S.A.R.L.·Product code MBB·December 1, 2016

    OPTIPAC-S 60 REFOBACIN BONE CEMENT R

    FDA Adverse Event
    Malfunction ·BIOMET FRANCE S.A.R.L.·Product code MBB·June 14, 2016

    REFOBACIN BONE CEMENT R 2X40G

    FDA Adverse Event
    Malfunction ·BIOMET FRANCE S.A.R.L.·Product code MBB·February 2, 2018

    OPTIPAC-S KNEE REFOBACIN PLUS BONE CEMNT

    FDA Adverse Event
    Malfunction ·BIOMET FRANCE S.A.R.L.·Product code MBB·May 25, 2016

    BIOMET BONE CEMENT 1X40G

    FDA Adverse Event
    Malfunction ·BIOMET FRANCE S.A.R.L.·Product code MBB·July 22, 2016

    BIOMET BONE CEMENT R 2X40G

    FDA Adverse Event
    Malfunction ·BIOMET FRANCE S.A.R.L.·Product code MBB·July 9, 2016

    OPTIPAC-S 60 REFOBACIN BONE CEMENT R

    FDA Adverse Event
    Malfunction ·BIOMET FRANCE S.A.R.L.·Product code MBB·May 23, 2016