BEUDAMED
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    NexGen Option Stemmed Tibial Component Size 6, Item Number 00-5986-047-02

    FDA Recall
    Open, Classified ·Zimmer, Inc.·Product code JWH·December 6, 2022

    NexGen Option Stemmed Tibial Component Size 8, Item Number 00-5986-057-02

    FDA Recall
    Open, Classified ·Zimmer, Inc.·Product code JWH·December 6, 2022

    NexGen Option Stemmed Tibial Component Size 4, Item Number 00-5986-037-02

    FDA Recall
    Open, Classified ·Zimmer, Inc.·Product code JWH·December 6, 2022

    NexGen Option Stemmed Tibial Component Size 7, Item Number 00-5986-057-01

    FDA Recall
    Open, Classified ·Zimmer, Inc.·Product code JWH·December 6, 2022

    NexGen Option Stemmed Tibial Component Size 3, Item Number 00-5986-037-01

    FDA Recall
    Open, Classified ·Zimmer, Inc.·Product code JWH·December 6, 2022

    NexGen Option Stemmed Tibial Component Size 5, Item Number 00-5986-047-01

    FDA Recall
    Open, Classified ·Zimmer, Inc.·Product code JWH·December 6, 2022

    Attune Revision Limb Preservation System (LPS) Tibial Insert SM 12MM, Part Number 151760312

    FDA Recall
    Open, Classified ·DePuy Orthopaedics, Inc.·Product code KRO·February 15, 2023

    Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 26MM, Part Number 151760226

    FDA Recall
    Open, Classified ·DePuy Orthopaedics, Inc.·Product code KRO·February 15, 2023

    Attune Revision Limb Preservation System (LPS) Tibial Insert XXSM 18MM, Part Number 151760118

    FDA Recall
    Open, Classified ·DePuy Orthopaedics, Inc.·Product code KRO·February 15, 2023

    Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 12MM, Part Number 151760212

    FDA Recall
    Open, Classified ·DePuy Orthopaedics, Inc.·Product code KRO·February 15, 2023

    NexGen LPS Flex, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis, Model Number 00-5962-042-10

    FDA Recall
    Open, Classified ·Zimmer, Inc.·Product code JWH·February 27, 2025

    Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHRWR100 - Product Usage: The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. The device is intended for Professional use only.

    FDA Recall
    Open, Classified ·Axis-Shield Diagnostics, Ltd. 17 Luna Place Dundee United Kingdom·Product code LPS·September 16, 2019

    cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test for total L-homocysteine

    FDA Recall
    Open, Classified ·Roche Diagnostics Operations, Inc.·Product code LPS·October 17, 2024

    Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHBC100 - Product Usage: The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. The device is intended for Professional use only.

    FDA Recall
    Open, Classified ·Axis-Shield Diagnostics, Ltd. 17 Luna Place Dundee United Kingdom·Product code LPS·September 16, 2019

    Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHRWR1000 - Product Usage: The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. The device is intended for Professional use only.

    FDA Recall
    Open, Classified ·Axis-Shield Diagnostics, Ltd. 17 Luna Place Dundee United Kingdom·Product code LPS·September 16, 2019

    Alcon Custom Pak Surgical Procedure Pack: Pak Number & Pak Description: 17533-04 DR GROSS LPS LLC 18704-03 CATARACT SURGI CARE 18382-03 DR GEORGE ZAMBELLI BEAVER VALLEY ASC 8685-21 CATARACT PACK EYE SURGICAL CNTR OF AR 19451-02 DR ROESKE PACK INLAND VALLEY SURGERY CTR 19136-03 OCCULOPLASTIC WILMINGTON EYE 18401-03 MCGRAW SIGHTPATH MEDICAL 16032-05 MIDDLE TENNESSEE PACK SIGHTPATH MEDICAL 17570-05 CATARACT CENTURION FORT MADISON COMM HOS 19002-02 CATARACT BAPTIST HEALTH SURGERY CENTER 10560-14 CATARACT - NORTH CENTRAL 1 SIGHTPATH MED 16877-11 DR DAVID B LEACH CLEARVIEW SURGERY CENTE 19061-02 HOSLER UNIVERSITY SURGI CENTER 18911-02 MASON CATARACT THE ASC AT UNITED MEDICAL 17469-02 GENERAL CUSTOM PACK SHARP MEMORIAL HOSPI 18917-01 CATARACT 2 SURGERY CENTER OF THE TEMECUL 17115-06 DR SCZEPANSKI NORTH DAKOTA EYE CLINIC 17780-04 OPHTHALMIC TEXAS PRECISION SURGERY CENTE 2452-58 CATARACT BOLSA OUTPATIENT SURG CTR 19096-01 OPHTHALMIC EAST ALABAMA AMB SURGERY CENT 18023-04 OPHTHALMIC BRAINARD SURGERY CENTER 17039-13 EYE-Q COMPLETE CAT PAK VISION CARE SURG 5300-61 CATARACT WOODLAND MEM HOSP

    FDA Recall
    Open, Classified ·Alcon Research, LLC·Product code LRO·March 10, 2023

    Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit

    FDA Recall
    Open, Classified ·ROi CPS LLC·Product code OEZ·September 21, 2023

    Sterile surgical convenience kits: 1. regard Item Number: 800756005, NU00961E - OH Laminectomy Cust Pack; 2. regard Item Number: 880411008, NU01018H - Lumbar Universal ; 3. regard Item Number: 880396007, NU01001G - Craniotomy ; 4. regard Item: 880387005, NU00991E - Ant/Cervical Spine ; and 5. regard Item Number: 800716005, NU00921E - ORMC Major Crani Pack.

    FDA Recall
    Open, Classified ·ROi CPS LLC·Product code OJG·March 22, 2023

    Sterile surgical convenience kit: regard Item Number 800706005, LD0091E - OH C-Section Pack.

    FDA Recall
    Open, Classified ·ROi CPS LLC·Product code OHM·March 22, 2023

    regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit to be used in Labor and Delivery.

    FDA Recall
    Open, Classified ·ROi CPS LLC·Product code MLS·December 26, 2024