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    OPTETRAK TOTAL KNEE SYSTEM SIZE 0/1 DELTA (LINE EXTENSION)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    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

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

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040007822·Zirlux 16+ B4 89x17x10

    DESIGN OPTICS

    FDA UDI
    FGX INTERNATIONAL INC.·00193033339374·

    DESIGN OPTICS

    FDA UDI
    FGX INTERNATIONAL INC.·00193033339329·

    DESIGN OPTICS

    FDA UDI
    FGX INTERNATIONAL INC.·00193033339336·

    DESIGN OPTICS

    FDA UDI
    FGX INTERNATIONAL INC.·00193033339343·

    DESIGN OPTICS

    FDA UDI
    FGX INTERNATIONAL INC.·00193033339312·

    DESIGN OPTICS

    FDA UDI
    FGX INTERNATIONAL INC.·00193033339350·

    DYNATECH MR 5000, CATALOG #011-976-0600

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    STC BARBITURATES INTERCEPT MICRO-PLATE EIA, MODEL 1108I

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    LORENZ STERNAL CLOSURE SYSTEM WITH MODULAR SCREW

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VITEK® 2 AST-ST01 TEST KIT

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, INC·Product code LON·October 24, 2017

    BD DIFCO¿ SALMONELLA H ANTISERUM SINGLE FACTOR 5

    FDA Adverse Event
    Malfunction ·LEE LABORATORIES, INC.·Product code GRM·July 28, 2025

    BD DIFCO¿ SALMONELLA H ANTISERUM SINGLE FACTOR 5

    FDA Adverse Event
    Malfunction ·LEE LABORATORIES, INC.·Product code GRM·July 25, 2025

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 20, 2013

    BRAVO

    FDA Adverse Event
    Malfunction ·GIVEN IMAGING LTD.·Product code FFT·February 10, 2011

    E360 VENTILATOR

    FDA Adverse Event
    Other ·NEWPORT MEDICAL INSTRUMENTS, INC.·Product code CBK·March 10, 2008

    5ML BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE, IN 10ML SYRINGE, 10 USP UNITS/ML

    FDA Adverse Event
    Death ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FOZ·July 12, 2018