BEUDAMED
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    MODIFICATION TO SYNCHRON LX CLINICAL CHEMISTRY SYSTEMS (LX20 AND LX20 PRO)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Versacryl

    FDA UDI
    Keystone Industries·H66810140341·HC Reline Kit, 2-50 g Pink Pwd. 2-60 ml pre-mix...

    Gaudi

    FDA UDI
    NETBIOLOGICS, LLC·G682G0140341·Fixation Screw, for Gaudi Plate, OD=4.0mm, LEN=...

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033555323·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033555347·

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0140040·Driver Shaft, T30 Split Tip Double End Cap Starter

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033555316·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033555293·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033555286·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033555330·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033555309·

    COAPTITE

    FDA Adverse Event
    Other ·MERZ AESTHETICS INC·Product code LNM·November 4, 2011

    MONITECT MULTIPLE DRUG SCREEN TESTS, MODEL BC12,BC14,TC10,PC11, AND PC12

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    DOUBLE LUMEN URETHANE PICC LINE, MODEL UPICDS-

    FDA 510(k)
    FDA Class 2 ·General Hospital

    COAPTITE INJECTABLE IMPLANT

    FDA Adverse Event
    Other ·MERZ AESTHETICS, INC (FORMERLY BIOFORM MEDICAL, INC)·Product code LNM·October 29, 2010

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 21, 2013

    ZEPHYR XL DR

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·March 10, 2011

    VISIPORT PLUS 5MM-11MM TROCAR

    FDA Adverse Event
    Malfunction ·PONCE - USS·Product code GCJ·March 14, 2008

    WALLACH LL 100 cryosurgical units: LL100 Cryosurgical - Part Number 900001; LL110 with Pinned Yoke - Part Number 900019-70; LL100 Multi Tip W/TC - Part Number: 900629; LL100 - CO2 - Part Number 900162

    FDA Enforcement
    Class II ·Terminated·CooperSurgical, Inc.·April 22, 2015

    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, 200-16-XX; b. OPTETRAK All-polyethylene PS Tibial Components, with Product Line Numbers: 204-11-XX, 204-12-XX, 204-13-XX, 204-14-XX, 204-15-XX, 204-16-XX; c. OPTETRAK HI-FLEX PS Polyethylene Tibial Inserts, with Product Line Numbers: 244-20-XX, 244-21-XX, 244-22-XX, 244-23-XX, 244-24-XX, 244-25-XX; d. OPTETRAK CR Tibial Inserts, with Product Line Numbers: 200-21-XX, 200-22-XX, 200-23-XX, 200-24-XX, 200-25-XX, 200-26-XX, 200-50-XX, 200-51-XX; e. OPTETRAK CR Tibial Slope + Insert, with Product Line Numbers: 200-56-XX, 200-57-XX, 200-61-XX, 200-62-XX, 200-63-XX, 200-64-XX, 200-65-XX; f. OPTETRAK CR Tibial Slope ++ Insert, with Product Line Numbers: 200-57-XX, 200-71-XX, 200-72-XX, 200-73-XX, 200-74-XX, 200-75-XX; g. OPTETRAK PS Tibial Inserts, with Product Line Numbers: 204-21-XX, 204-22-XX 204-23-XX, 204-24-XX, 204-25-XX, 204-26-XX, 204-50-XX, 204-51-XX; h. OPTETRAK "MOMB" Non-Mod Molded Insert, with Product Line Numbers: 204-91-XX, 204-92-XX, 204-93-XX, 204-94-XX, 204-95-XX; i. OPTETRAK CC Tibial Insert, with Product Line Numbers: 208-21-XX, 208-22-XX, 208-23-XX, 208-24-XX, 208-25-XX, 208-51-XX; j. OPTETRAK B-Series PS Tibial Insert, with Product Line Numbers: 224-21-XX, 224-22-XX, 224-23-XX, 224-24-XX. Affected 510(k) numbers include: K932690, K933494, K932776, K011976, K082022, K933610, K030686, K954208, K010434, K033883. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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