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    PERFECTA TOTAL HIP SYSTEM, HA COATED

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EQUISTREAM XK Alphacurve Long-Term Hemodialysis Catheter

    FDA UDI
    Bard Access Systems, Inc.·00801741013898·EQUISTREAM XK HEMODIALYSIS CATH, ALPHACURVE, A...

    DIASTAT ENA PROFILE

    FDA 510(k)
    FDA Class 2 ·Immunology

    BARD MONOPTY DISPOSABLE CORE BIOPSY INSTRUMENT

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    DEPUY ASR XL FEM IMP SIZE 47

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD.·Product code KWA·January 15, 2013

    TRANSPORT SERIES

    FDA Adverse Event
    Malfunction ·STRYKER CORP., MEDICAL DIV.·Product code FPO·November 16, 2010

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 7, 2014

    SYRINGE,BULB,2OZ/60CC,GREEN, Part: 300055070, packaged inside Alcon Custom-Pak Surgical Procedure Packs, Products: 18018-06, 3865-44, 5675-76, 13554-11, 18018-06, 15190-16 , 15190-16, 15190-16, 15190-16, 15190-16, 13554-11, 5918-39, 15190-16, 15190-16, 9208-66, 9208-66, 5675-76, 5918-39, 9208-66, 15190-16, 9065-25, 5918-39, 16066-15, 16066-15

    FDA Enforcement
    Class II ·Ongoing·Alcon Research, LLC·April 3, 2024

    SYRINGE,BULB,2OZ/60CC,GREEN, Part: 300055070, packaged inside Alcon Custom-Pak Surgical Procedure Packs, Products: 18018-06, 3865-44, 5675-76, 13554-11, 18018-06, 15190-16 , 15190-16, 15190-16, 15190-16, 15190-16, 13554-11, 5918-39, 15190-16, 15190-16, 9208-66, 9208-66, 5675-76, 5918-39, 9208-66, 15190-16, 9065-25, 5918-39, 16066-15, 16066-15

    FDA Recall
    Open, Classified ·Alcon Research, LLC·Product code LRO·February 21, 2024

    Alteon XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G00 22MM 140-28-50 NV EHXLNTRL LNR G0 28MM 140-28-51 NV EHXLNTRL LNR G1 28MM 140-28-52 NV EHXL NTRL LNR G228MM 140-32-51 NV EHXL NTRL LNR G132MM 140-32-52 NV EHXL NTRL LNR G232MM 140-32-53 NV EHXL NTRL LNR G332MM 140-32-54 NV EHXLNTRL LNR G4 32MM 140-32-55 NV EHXLNTRL LNR G5 32MM 140-36-52 NV EHXLNTRL LNR G2 36MM 140-36-53 NV EHXL NTRL LNR G336MM 140-36-54 NV EHXLNTRL LNR G4 36MM 140-36-55 NV EHXLNTRL LNR G5 36MM 140-40-53 NV EHXLNTRL LNR G3 40MM 140-40-54 NV EHXLNTRL LNR G4 40MM 140-40-55 NV EHXLNTRL LNR G5 40MM 142-22-68 NV EHXL ALPLNR G00 22MM 142-22-70 NV EHXL LIPLNR G00 22MM 142-28-50 NV EHXL LIP LNR G0 28MM 142-28-51 NV EHXL LIP LNR G1 28MM 142-28-52 NV EHXL LIP LNR G2 28MM 142-28-60 NV EHXL ALIPLNR G0 28MM 142-28-61 NV EHXL ALIP LNR G1 28MM 142-28-62 NV EHXL ALIP LNR G2 28MM 142-32-51 NV EHXL LIP LNR G1 32MM 142-32-52 NV EHXL LIP LNR G2 32MM 142-32-53 NV EHXL LIP LNR G3 32MM 142-32-54 NV EHXL LIP LNR G4 32MM 142-32-55 NV EHXL LIP LNR G5 32MM 142-32-61 NV EHXL ALIP LNR G1 32MM 142-32-62 NV EHXL ALIP LNR G2 32MM 142-32-63 NV EHXL ALIP LNR G3 32MM 142-32-64 NV EHXL ALIP LNR G4 32MM 142-32-65 NV EHXL ALIP LNR G5 32MM 142-36-52 NV EHXL LIP LNR G2 36MM 142-36-53 NV EHXL LIP LNR G3 36MM 142-36-54 NV EHXL LIP LNR G4 36MM 142-36-55 NV EHXL LIP LNR G5 36MM 142-36-62 NV EHXL ALIP LNR G2 36MM 142-36-63 NV EHXL ALIP LNR G3 36MM 142-36-64 NV EHXL ALIP LNR G4 36MM 142-36-65 NV EHXL ALIP LNR G5 36MM 142-40-53 NV EHXL LIP LNR G3 40MM 142-40-54 NV EHXL LIP LNR G4 40MM 142-40-55 NV EHXL LIP LNR G5 40MM 142-40-63 NV EHXL ALIP LNR G3 40MM 142-40-64 NV EHXL ALIP LNR G4 40MM 142-40-65 NV EHXL ALIP LNR G5 40MM 146-22-70 NV EHXL LATLNR G00 22MM 146-28-51 NV EHXL LAT LNR G1 28MM 146-32-51 NV EHXL LAT LNR G1 32MM 146-32-52 NV EHXL LAT LNR G2 32MM 146-32-53 NV EHXL LAT LNR G3 32MM 146-32-54 NV EHXL LAT LNR G4 32MM 146-32-55 NV EHXL LAT LNR G5 32MM 146-36-52 NV EHXL LAT LNR G2 36MM 146-36-53 NV EHXL LAT LNR G3 36MM 146-36-54 NV EHXL LAT LNR G4 36MM 146-36-55 NV EHXL LAT LNR G5 36MM 146-40-53 NV EHXL LAT LNR G3 40MM 146-40-54 NV EHXL LAT LNR G4 40MM 146-40-55 NV EHXL LAT LNR G5 40MM 148-32-51 NV EHXL 10¿ LNR G1 32MM 148-36-52 NV EHXL 10¿ LNR G2 36MM 148-36-53 NV EHXL 10¿ LNR G3 36MM 148-36-54 NV EHXL 10¿ LNR G4 36MM 148-36-55 NV EHXL 10¿ LNR G5 36MM 148-40-53 NV EHXL 10¿ LNR G3 40MM 148-40-54 NV EHXL 10¿ LNR G4 40MM 148-40-55 NV EHXL 10¿ LNR G5 40MM All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·February 19, 2025

    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