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    IMPIX MANTA+, REF numbers: a) B20171743, b) B20171753, c) B20171763, d) B20171773, e) B20171943, f) B20171953, g) B20171963, h) B20171973, i) B20172253, j) B20172263, k) B20172273; intervertebral fusion device - cervical

    FDA Recall
    Open, Classified ·Medicrea International Vancia Vancia Rillieux La Pape France·Product code ODP·July 12, 2023

    Brand Name: CONSTRUX" Mini PTC Spacer System Product Name: CONSTRUX" Mini PTC Spacer System Model/Catalog Number: 37-3106SP 12mm W X 12mm L, 6mm H, Parallel; 37-3107SP 12mm W X 12mm L, 7mm H, Parallel; 37-3108SP 12mm W X 12mm L, 8mm H, Parallel; 37-3109SP 12mm W X 12mm L, 9mm H, Parallel; 37-3110SP 12mm W X 12mm L, 10mm H, Parallel; 37-3111SP 12mm W X 12mm L, 11mm H, Parallel; 37-3112SP 12mm W X 12mm L, 12mm H, Parallel; 37-3113SP 12mm W X 12mm LW, 13mm H, Parallel; 37-3114SP 12mm W X 12mm WL, 14mm H, Parallel; 37-3006SP 12mm W X 12mm L, 6mm H, 5 Lordotic; 37-3007SP 12mm W X 12mm L, 7mm H, 5 Lordotic; 37-3008SP 12mm W X 12mm L, 8mm H, 5 Lordotic; 37-3009SP 12mm WL X 12mm L, 9mm H, 5 Lordotic; 37-3010SP 12mm W X 12mm L, 10mm H, 5 Lordotic; 37-3011SP 12mm W X 12mm L, 11mm H, 5 Lordotic; 37-3012SP 12mm W X 12mm L, 12mm H, 5 Lordotic; 37-3013SP 12mm W X 12mm L, 13mm H, 5 Lordotic; 37-3014SP 12mm W X 12mm L, 14mm H, 5 Lordotic; 37-3207SP 12mm W X 12mm L, 7mm H, 10 Lordotic; 37-3208SP 12mm W X 12mm L, 8mm H, 10 Lordotic; 37-3209SP 12mm W X 12mm L, 9mm H, 10 Lordotic; 37-3210SP 12mm W X 12mm L, 10mm H, 10 Lordotic; 37-3211SP 12mm W X 12mm L, 11mm H, 10 Lordotic; 37-3212SP 12mm W X 12mm L, 12mm H, 10 Lordotic; 37-4106SP 15mm W X 12mm L, 6mm H, Parallel; 37-4107SP 15mm W X 12mm L, 7mm H, Parallel; 37-4108SP 15mm W X 12mm L, 8mm H, Parallel; 37-4109SP 15mm W X 12mm L, 9mm H, Parallel; 37-4110SP 15mm W X 12mm L, 10mm H, Parallel; 37-4111SP 15mm W X 12mm L, 11mm H, Parallel; 37-4112SP 15mm W X 12mm L, 12mm H, Parallel; 37-4113SP 15mm W X 12mm L, 13mm H, Parallel; 37-4114SP 15mm W X 12mm L, 14mm H, Parallel; 37-4006SP 15mm W X 12mm L, 6mm H, 5 Lordotic; 37-4007SP 15mm W X 12mm L, 7mm H, 5 Lordotic; 37-4008SP 15mm W X 12mm L, 8mm H, 5 Lordotic; 37-4009SP 15mm W X 12mm L, 9mm H, 5 Lordotic; 37-4010SP 15mm W X 12mm L, 10mm H, 5 Lordotic; 37-4011SP 15mm W X 12mm L, 11mm H, 5 Lordotic; 37-4012SP 15mm W X 12mm L, 12mm H, 5 Lordotic; 37-4013SP 15mm W X 12mm L, 13mm H, 5 Lordotic; 37-4014SP 15mm W X 12mm L, 14mm H, 5 Lordotic; 37-4207SP 15mm W X 12mm L, 7mm H, 10 Lordotic; 37-4208SP 15mm W X 12mm L, 8mm H, 10 Lordotic; 37-4209SP 15mm W X 12mm L, 9mm H, 10 Lordotic; 37-4210SP 15mm W X 12mm L, 10mm H, 10 Lordotic; 37-4211SP 15mm W X 12mm L, 11mm H, 10 Lordotic; 37-4212SP 15mm W X 12mm L, 12mm H, 10 Lordotic; 37-5106SP 15mm W X 15mm L, 6mm H, Parallel; 37-5107SP 15mm W X 15mm L, 7mm H, Parallel 37-5108SP 15mm W X 15mm L, 8mm H, Parallel; 37-5109SP 15mm W X 15mm L, 9mm H, Parallel; 37-5110SP 15mm W X 15mm L, 10mm H, Parallel; 37-5111SP 15mm W X 15mm L, 11mm H, Parallel; 37-5112SP 15mm W X 15mm L, 12mm H, Parallel; 37-5113SP 15mm W X 15mm L, 13mm H, Parallel; 37-5114SP 15mm W X 15mm L, 14mm H, Parallel; 37-5006SP 15mm W X 15mm L, 6mm H, 5 Lordotic; 37-5007SP 15mm W X 15mm L, 7mm H, 5 Lordotic; 37-5008SP 15mm W X 15mm L, 8mm H, 5 Lordotic; 37-5009SP 15mm W X 15mm L, 9mm H, 5 Lordotic; 37-5010SP 15mm W X 15mm L, 10mm H, 5 Lordotic; 37-5011SP 15mm W X 15mm L, 11mm H, 5 Lordotic; 37-5012SP 15mm W X 15mm L, 12mm H, 5 Lordotic; 37-5013SP 15mm W X 15mm L, 13mm H, 5 Lordotic; 37-5014SP 15mm W X 15mm L, 14mm H, 5 Lordotic; 37-5207SP 15mm W X 15mm L, 7mm H, 10 Lordotic; 37-5208SP 15mm W X 15mm L, 8mm H, 10 Lordotic; 37-5209SP 15mm W X 15mm LW, 9mm H, 10 Lordotic; 37-5210SP 15mm W X 15mm L, 10mm H, 10 Lordotic; 37-5211SP 15mm W X 15mm L, 11mm H, 10 Lordotic; 37-5212SP 15mm W X 15mm L, 12mm H, 10 Lordotic;

    FDA Recall
    Open, Classified ·Orthofix U.S. LLC·Product code ODP·November 3, 2025

    IMPIX C+, REF numbers: a) B20240104, b) B20240105, c) B20240106, d) B20240107, e) B20240205, f) B20240206, g) B20240207, h) B20240208; intervertebral fusion device - cervical

    FDA Recall
    Open, Classified ·Medicrea International Vancia Vancia Rillieux La Pape France·Product code ODP·July 12, 2023

    Brand Name: CONSTRUX" Mini Ti Spacer System Product Name: CONSTRUX" Mini Ti Spacer System Model/Catalog Number: 37-6005SP 12mm W X 12mm L, 5mm H, 5 Lordotic 37-6005SP 12mm W X 12mm L, 5mm H, 5 Lordotic 37-6005SP 12mm W X 12mm L, 5mm H, 5 Lordotic 37-6006SP 12mm W X 12mm L, 6mm H, 5 Lordotic 37-6006SP 12mm W X 12mm L, 6mm H, 5 Lordotic 37-6006SP 12mm W X 12mm L, 6mm H, 5 Lordotic 37-6007SP 12mm W X 12mm L, 7mm H, 5 Lordotic 37-6007SP 12mm W X 12mm L, 7mm H, 5 Lordotic 37-6007SP 12mm W X 12mm L, 7mm H, 5 Lordotic 37-6008SP 12mm W X 12mm L, 8mm H, 5 Lordotic 37-6008SP 12mm W X 12mm L, 8mm H, 5 Lordotic 37-6008SP 12mm W X 12mm L, 8mm H, 5 Lordotic 37-6009SP 12mm W X 12mm L, 9mm H, 5 Lordotic 37-6009SP 12mm W X 12mm L, 9mm H, 5 Lordotic 37-6009SP 12mm W X 12mm L, 9mm H, 5 Lordotic 37-6010SP 12mm W X 12mm L, 10mm H, 5 Lordotic 37-6010SP 12mm W X 12mm L, 10mm H, 5 Lordotic 37-6010SP 12mm W X 12mm L, 10mm H, 5 Lordotic 37-6011SP 12mm W X 12mm L, 11mm H, 5 Lordotic 37-6011SP 12mm W X 12mm L, 11mm H, 5 Lordotic 37-6011SP 12mm W X 12mm L, 11mm H, 5 Lordotic 37-6012SP 12mm W X 12mm L, 12mm H, 5 Lordotic 37-6012SP 12mm W X 12mm L, 12mm H, 5 Lordotic 37-6012SP 12mm W X 12mm L, 12mm H, 5 Lordotic 37-6105SP 12mm W X 12mm L, 5mm H, Parallel 37-6105SP 12mm W X 12mm L, 5mm H, Parallel 37-6105SP 12mm W X 12mm L, 5mm H, Parallel 37-6106SP 12mm W X 12mm L 6mm H, Parallel 37-6106SP 12mm W X 12mm L 6mm H, Parallel 37-6106SP 12mm W X 12mm L 6mm H, Parallel 37-6107SP 12mm W X 12mm L, 7mm H, Parallel 37-6107SP 12mm W X 12mm L, 7mm H, Parallel 37-6107SP 12mm W X 12mm L, 7mm H, Parallel 37-6108SP 12mm W X 12mm L, 8mm H, Parallel 37-6108SP 12mm W X 12mm L, 8mm H, Parallel 37-6108SP 12mm W X 12mm L, 8mm H, Parallel 37-6109SP 12mm W X 12mm L, 9mm H, Parallel 37-6109SP 12mm W X 12mm L, 9mm H, Parallel 37-6109SP 12mm W X 12mm L, 9mm H, Parallel 37-6110SP 12mm W X 12mm L, 10mm H, Parallel 37-6110SP 12mm W X 12mm L, 10mm H, Parallel 37-6110SP 12mm W X 12mm L, 10mm H, Parallel 37-6111SP 12mm W X 12mm L, 11mm H, Parallel 37-6111SP 12mm W X 12mm L, 11mm H, Parallel 37-6111SP 12mm W X 12mm L, 11mm H, Parallel 37-6112SP 12mm W X 12mm L, 12mm H, Parallel 37-6112SP 12mm W X 12mm L, 12mm H, Parallel 37-6112SP 12mm W X 12mm L, 12mm H, Parallel 37-6206SP 12mm W X 12mm L, 6mm H, 10 Lordotic 37-6206SP 12mm W X 12mm L, 6mm H, 10 Lordotic 37-6206SP 12mm W X 12mm L, 6mm H, 10 Lordotic 37-6207SP 12mm W X 12mm L, 7mm H, 10 Lordotic 37-6207SP 12mm W X 12mm L, 7mm H, 10 Lordotic 37-6207SP 12mm W X 12mm L, 7mm H, 10 Lordotic 37-6208SP 12mm W X 12mm L, 8mm H, 10 Lordotic 37-6208SP 12mm W X 12mm L, 8mm H, 10 Lordotic 37-6208SP 12mm W X 12mm L, 8mm H, 10 Lordotic 37-6209SP 12mm W X 12mm L, 9mm H, 10 Lordotic 37-6209SP 12mm W X 12mm L, 9mm H, 10 Lordotic 37-6209SP 12mm W X 12mm L, 9mm H, 10 Lordotic 37-6210SP 12mm W X 12mm L, 10mm H, 10 Lordotic 37-6210SP 12mm W X 12mm L, 10mm H, 10 Lordotic 37-6210SP 12mm W X 12mm L, 10mm H, 10 Lordotic 37-6211SP 12mm W X 12mm L, 11mm H, 10 Lordotic 37-6211SP 12mm W X 12mm L, 11mm H, 10 Lordotic 37-6211SP 12mm W X 12mm L, 11mm H, 10 Lordotic

    FDA Recall
    Open, Classified ·Orthofix U.S. LLC·Product code ODP·November 3, 2025

    IMPIX MANTA, REF numbers: a) A20150407, b) A20250407, c) A20350567, d) B20181743, e) B20181753, f) B20181763, g) B20181773, h) B20181943, i) B20181953, j) B20181963, k) B20181973, l) B20182253, m) B20182263; intervertebral fusion device - lumbar

    FDA Recall
    Open, Classified ·Medicrea International Vancia Vancia Rillieux La Pape France·Product code ODP·July 12, 2023

    ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Component of the ATTUNE Total Knee Replacement System.

    FDA Recall
    Open, Classified ·DePuy Orthopaedics, Inc.·Product code MBH·March 12, 2024

    Platelet Aggregation Kit, Cat. No.5369, For use in platelet aggregation studies, Contains: 2X1 mL ADP Reagent containing adenosine diphosphate, 2X 1 mL Collagen Reagent containing collagen (equine tendon), 2 x 1 mL Epinephrine Reagent containing L-epinephrine, FOR IN-VITRO DIAGNOSTIC USE, Store at 2 to 8 C, 0011724/14(3)

    FDA Recall
    Open, Classified ·Helena Laboratories, Corp.·Product code GHR·May 23, 2018

    4500MD Triple Quad Mass Spectrometer, Part Number 5032522

    FDA Recall
    Open, Classified ·AB Sciex, LLC·Product code DOP·August 30, 2023

    Beckman Coulter Access Free T3, Triiodothyronine, Free, Catalog #A13422, each box contains 2 reagent packs.

    FDA Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code CDP·March 15, 2023

    Citrine Triple Quad Mass Spectrometer, Part Number 5063684

    FDA Recall
    Open, Classified ·AB Sciex, LLC·Product code DOP·August 30, 2023

    API3200MD Mass Spectrometer, Part Number 4466230

    FDA Recall
    Open, Classified ·AB Sciex, LLC·Product code DOP·August 30, 2023

    VITROS Immunodiagnostic Products Free T3 Reagent Pack-IVD is for the quantitative measurement of free triiodothyronine (FT3) in human serum and plasma (EDTA or heparin). Product Code: 131 5589

    FDA Recall
    Open, Classified ·QUIDELORTHO·Product code CDP·April 9, 2024

    Citrine QTRAP Mass Spectrometer, Part Number 5063685

    FDA Recall
    Open, Classified ·AB Sciex, LLC·Product code DOP·August 30, 2023

    R&D CBC-3D Hematology Control: (1) CBC-3D Normal Pack Hematology Control, REF 3D501, containing 10 x 2.0mL Control N; (2) CBC-3D TRI PACK Hematology Control, REF 3D503, containing 4 x 2.0 mL Controls L, N, and H; (3) CBC-3D for Mythic 18 Hematology Control, REF 3D503RX, containing 2 x 2.0 mL each Controls L, N, and H; (4) CBC-3D For MINDRAY Hematology Control, REF 3D506, containing 2 x 3.0 mL each Controls L, N, and H; (5) CBC-3D For MINDRAY Hematology Control, REF 3D506US, containing 2 x 3.0 mL each Controls L, N, and H; (6) CBC-3D TRI PACK Hematology Control, REF 3D507, containing 4 x 2.0 mL each Controls L, N, and H; (7) CBC-3D TRI PACK Hematology Control, REF 3D508, containing 2 x 2.0 m each Controls L, N, and H; (8) CBC-3D For ABACUS, REF D3D02 Hematology Control, containing 2 x 3.0 mL each Controls L, N, and H; (9) CBC-3D For ABACUS Hematology Control, REF D3D04, containing 4 x 3.0 mL each Controls L, N, and H. Loose tubes labeled CBC-3D Hematology Control in 2.0mL and 3.0mL sizes. OEM/Own-label distributor labels: (1) Alere 380 Hemo Control (L-N-H), REF AL35004-KIT, containing 2 x 3.0 mL each Controls L, N, and H; Kit lot #B1122; control lot #B1122N, no UDI (2) diatron Diacon 3 Hematology Control, Normal Level, 3.0 mL tubes, lot #B1122N (3) diatron Diacon 3 Hematology Control, REF DN35002-SET, containing 6 x 3.0 mL Control N, kit lot #B1122, control lot #B1122N (4) diatron Diacon 3 Hematology Control, REF DN35004-KIT, containing 2 x 3.0 mL each Controls L, N, and H, kit lot #B1122, Normal control lot #B1122N. (5) Elite 3 HEM Control Normal, REF HEM00014, containing 6 x 3.0 mL Normal controls, kit lot #B1122, control lot #B1122N; (6) Erba H3 CON N, REF HEM00034, 3 mL vials, lot #E1122N, exp. 2023-02-10 (7) Horiba Medical Minotrol 16 Whole Blood Hematology Control, Cat. #5300000277, containing 3 x 2.5mL tubes (1 each Control 1, Control 2 (Normal), and Control 3; Cat. #5300000278, containing 6 x 2.5mL tubes (2 each Control 1, Control 2 (Normal), and Control 3; and Cat. #5300000283, containing 12 x 2.5mL tubes (4 each Control 1, Control 2 (Normal), and Control 3; kit lot #MX438, exp. 2023-01-05, Control 2 lot #MX438N. (8) 2022 3rd Test Event, CBC PLT 3 PART DIFF 2022-912-3D; and 2022 3rd Test Event, CBC PLT 3 PART DIFF 2022-914-3D. (9) mindray BC-3D, P/N 040-001423-00. (10) MINDRAY BC-3D CONTROL, REF BC3D01, containing 1 x 3.0 mL Controls L, N, and H; REF BC3D02, containing 2 x 3.0 mL Controls L, N, and H; and REF BC3D6N, containing 6 x 3.0 mL Control N; kit lot #B1122, control lot #B1122N. (11) MINDRAY BC-3D CONTROL, REF BC3D02US, containing 2 x 3.0 mL Level L, N, and H, kit lot number B1122, control lot #B1122N. (12) Nihon Kohden MEK-3D Hematology Control, REF 3DN03, containing MEK-3DN x 3 tubes; REF 3DN06, containing MEK-3DN x 6 tubes; and REF 3DN12, containing MEK-3DN x 12 tubes, kit lot #B22Y, control lot #B22YN. (13) Nihon Kohden MEK-3DN Normal Hematology Control tubes, 2.0 mL, lot #B22YN. (14) Orphee MYT-3D, REF MYT301, containing 2 x 2.5 mL Control N; REF MYT302, containing 2 x 2.5 mL each Controls L, N, and H; REF MYT304N, containing 4 x 2.5 mL Control N; REF 306N, containing 6 x 2.5 mL Control N; kit lot #B1122, control lot #B1122N; Myt-3D VET, REF MYT303-VET, containing 1 x 2.5 mL each Control L, N, and H. (15) Siemens ADVIA 360 Control, REF 11170853, containing 2 x 3.0 mL each Controls Low, Normal & High, kit lot #B0822, GTIN 00630414600833, control lot #B1122N. (16) URIT HQ-3DIFF, REF 5411000306, containing 2 x 3.0 mL each Controls L, N, and H, kit lot #B1122, control lot #B1122N; URIT HQ-3DIFF Hematology Control N tubes, 3.0 mL, lot #B1122N. (17) Woodley Haematology Control, REF WD1154, containing 6 x 2.0 mL Control N; and REF WD1154A, containing 2 x 2.0 mL each Controls L, N, and H, kit lot number B1122, control lot #B1122N;

    FDA Recall
    Open, Classified ·R & D Systems, Inc.·Product code JPK·November 7, 2022