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Product Description
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Recall Class
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FDA Recall Posting Date
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Recalling Firm
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SCORPIO U-DOME PATELLA -Intended for knee replacement
Part Number: 73-3708
|
2
|
01/31/2024
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Howmedica Osteonics Corp.
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SCORPIO U-DOME PATELLA -Intended for knee replacement
Part Number: 73-3710
|
2
|
01/31/2024
|
Howmedica Osteonics Corp.
|
SCORPIO U-DOME PATELLA -Intended for knee replacement
Part Number: 73-3910
|
2
|
01/31/2024
|
Howmedica Osteonics Corp.
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Scorpio NRG Tibial Brg Insert Assy -Intended for knee replacement
Part Number: 82-2-0908 ...
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2
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01/31/2024
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Howmedica Osteonics Corp.
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Scorpio NRG Tibial Brg Insert Assy -Intended for knee replacement
Part Number: 82-2-0910
...
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2
|
01/31/2024
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Howmedica Osteonics Corp.
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HOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT
Intended for knee replacement
Part Number...
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2
|
01/31/2024
|
Howmedica Osteonics Corp.
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HOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT
Intended for knee replacement
Part Number: 62...
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2
|
01/31/2024
|
Howmedica Osteonics Corp.
|
HOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT
Intended for knee replacement
Part Number:...
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2
|
01/31/2024
|
Howmedica Osteonics Corp.
|
P7 28MM 10 DEGREE +4MM INSERT Intended for knee replacement
Part Number: 6302-6-107
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2
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01/31/2024
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Howmedica Osteonics Corp.
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P7 32MM 1O DEGREE +4MM INSERT
Intended for knee replacement
Part Number: 6302-6-307
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2
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01/31/2024
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Howmedica Osteonics Corp.
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LEFT SMALL-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement
Part Number: 6637-0-028
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2
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01/31/2024
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Howmedica Osteonics Corp.
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LEFT LARGE-PCA MOD.REV.DUR.REV.INSERT
Intended for knee replacement
Part Number: 6637-0-228
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2
|
01/31/2024
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Howmedica Osteonics Corp.
|
LEFT LARGE-PCA MOD.REV.DUR.REV.INSERT
Intended for knee replacement
Part Number: 6637-0-231
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2
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01/31/2024
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Howmedica Osteonics Corp.
|
LEFT X-LARGE-PCA MOD.REV.DUR.REV.INSERT
Intended for knee replacement.
Product Number: 6637-0-...
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2
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01/31/2024
|
Howmedica Osteonics Corp.
|
LEFT SMALL-PCA MOD.REV.DUR.REV.INSERT
Intended for knee replacement.
Product Number: 6637-0-...
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2
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01/31/2024
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Howmedica Osteonics Corp.
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RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT
Intended for knee replacement
Product Number: 6637-...
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2
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01/31/2024
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Howmedica Osteonics Corp.
|
RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT
Intended for knee replacement
Product Number: 6637-...
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2
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01/31/2024
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Howmedica Osteonics Corp.
|
RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT
Intended for knee replacement.
Product Number: 6637-0...
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2
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01/31/2024
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Howmedica Osteonics Corp.
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PRIMARY REV.TIB.INSERT-DURACON
Intended for knee replacement.
Product Number: 6637-4-031
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2
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01/31/2024
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Howmedica Osteonics Corp.
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LARGE PRIMARY REV.TIB.INSERT- DURACON
Intended for knee replacement
Product Number: 6637-4...
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2
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01/31/2024
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Howmedica Osteonics Corp.
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DURATION A-P LIPPED TIB.INSERT-DURAC
Intended for knee replacement
Product Number: 6642...
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2
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01/31/2024
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Howmedica Osteonics Corp.
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DURATION A-P LIPPED TIB.INSERT-DURAC
Intended for knee replacement
Product Number: 6642...
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2
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01/31/2024
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Howmedica Osteonics Corp.
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DURATION PLASTIC PATELLA-DURACON
Intended for knee replacement
Product Number: 6642-2...
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2
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01/31/2024
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Howmedica Osteonics Corp.
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DUR PCA MTK REV INS LFT
Intended for knee replacement
Product Number: 6728-2-609
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2
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01/31/2024
|
Howmedica Osteonics Corp.
|
DUR PCA MTK REV INS LFT
Intended for knee replacement
Product Number: 6728-2-611
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2
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01/31/2024
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Howmedica Osteonics Corp.
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DUR PCA MTK REV INS RT
Intended for knee replacement
Product Number: 6728-2-709
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2
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01/31/2024
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Howmedica Osteonics Corp.
|
DUR PCA MTK REV INS RT
Intended for knee replacement
Product Number: 6728-2-711
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2
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01/31/2024
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Howmedica Osteonics Corp.
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Custom procedural convenience kits and trays, Othopedic use, labeled as:
a) HIP FRACTURE, kit num...
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2
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01/26/2024
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American Contract Systems, Inc.
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Power Knee, REF: PKA10001, and PKA10003; with Power Knee Battery, REF: PKA10002
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2
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01/25/2024
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Ossur H / F
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Exactech Optetrak Logic PS Knee System, Catalog Numbers: 02-012-35-5009
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2
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01/18/2024
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Exactech, Inc.
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Exactech Truliant, Activit-E Knee Insert, Catalog Numbers:
a) 02-023-02-0029,
b) 02-023-02-0032...
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2
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01/18/2024
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Exactech, Inc.
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Exactech Optetrak Logic Knee System, Catalog Numbers:
a) 02-012-47-3011,
b) 02-012-47-5009,
c...
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2
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01/18/2024
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Exactech, Inc.
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Exactech Optetrak Knee System, Catalog Numbers:
a) 200-02-26,
b) 200-02-29,
c) 200-02-32,
d...
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2
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01/18/2024
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Exactech, Inc.
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Exactech Truliant Knee System, Catalog Numbers:
a) 02-012-35-3509,
b) 02-022-35-1509,
c) 02-0...
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2
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01/18/2024
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Exactech, Inc.
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Link Patella Glide Resection Guide- For the implantation of the Endo-Model Knee System as part of a ...
|
2
|
01/18/2024
|
Waldemar Link GmbH & Co. KG (Mfg Site)
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Iconix Knotless 1.4mm Anchor with XBraid S (Blue/Black) REF 3911-714-520
Iconix Knotless 1.4mm A...
|
2
|
12/08/2023
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Riverpoint Medical, LLC
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DJO surgical EMPOWR Porous Knee System Empowr 3D Femur-Porous Coated SIZE 8 Left 3D MATRIX COATED RE...
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2
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12/07/2023
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Encore Medical, LP
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DJO EMPOWR Knee Punch Handle, REF: 801-05-040
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2
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11/07/2023
|
Encore Medical, LP
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Unity Total Knee System, Model Number 112.001.34.
Primary and revision total knee arthroplasty
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2
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11/02/2023
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Corin Ltd
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Unity CR Femur Right, Size 6, Model Number 112.001.32
Primary and revision total knee arthropla...
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2
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11/02/2023
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Corin Ltd
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JOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6, REF 74027262; knee prosthesis
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2
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10/24/2023
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Smith & Nephew, Inc.
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JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 74029262; knee prosthesis
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2
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10/24/2023
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Smith & Nephew, Inc.
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EMPOWR 3D Knee Tibial Insert, 5R, 10MM, VE, REF: 342-10-705
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2
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10/12/2023
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Encore Medical, LP
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Procedure packs:
(1) Presource PBDS Cat. PN33BPCR2, Kit, Back, Sterile;
(2) Presource PBDS Cat. POC...
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2
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10/10/2023
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Cardinal Health 200, LLC
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Zimmer Dermatome Blades- 10-pack boxes of blades. Intended for use with the dermatome handpiece whic...
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2
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10/06/2023
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Zimmer Surgical Inc
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Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5)
Pr...
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2
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10/05/2023
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Blue Belt Technologies, Inc
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smith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, SIZE 5N, LEFT, NARROW, ...
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2
|
09/20/2023
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Smith & Nephew Inc
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DJO Surgical: Empowr Knee, Universal Tibia Baseplate, 6R, REF: 352-02-106
|
2
|
09/19/2023
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Encore Medical, LP
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Link OptiStem Rasp Handle-Used with the OptiStem Rasp to prepare the femoral medullary canal for a k...
|
2
|
08/29/2023
|
Waldemar Link GmbH & Co. KG (Mfg Site)
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The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging for...
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2
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08/24/2023
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Medtronic Navigation, Inc.-Littleton
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Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the fo...
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2
|
08/03/2023
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MEDLINE INDUSTRIES, LP - Northfield
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MRI Biomet Pin Guide for Total Knee Arthroplasty (Zimmer Biomet Patient Specific Instruments (PSI)--...
|
2
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07/20/2023
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Materialise N.V.
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Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:
a) TOTAL JOIN...
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2
|
07/20/2023
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MEDLINE INDUSTRIES, LP - Northfield
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MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: TOTAL KNEE THEDA, Model Number DYNJ9...
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2
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07/12/2023
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MEDLINE INDUSTRIES, LP - Northfield
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MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: a) TOTAL JOINT, Model Number CDS9855...
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2
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07/12/2023
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MEDLINE INDUSTRIES, LP - Northfield
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Custom medical procedure packs labeled as:
a) OPEN HEART TRACECART, REF '53-1941;
b) CARDIAC...
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2
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07/03/2023
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DeRoyal Industries Inc
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LinkSymphoKnee Distal Femoral Augment - Tilastan - Size 7-8, Medial-Right/Lateral Left, 5mm- Intende...
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2
|
07/03/2023
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Waldemar Link GmbH & Co. KG (Mfg Site)
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LinkSymphoKnee Distal Femoral Augment - Tilastan - Size. 7-8, Lateral-Right/Medial-Left, 5mm-Intende...
|
2
|
07/03/2023
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Waldemar Link GmbH & Co. KG (Mfg Site)
|
LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 4, Left
|
2
|
06/30/2023
|
Waldemar Link GmbH & Co. KG (Mfg Site)
|
LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Left
|
2
|
06/30/2023
|
Waldemar Link GmbH & Co. KG (Mfg Site)
|
LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 4, Right
|
2
|
06/30/2023
|
Waldemar Link GmbH & Co. KG (Mfg Site)
|
LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Right
|
2
|
06/30/2023
|
Waldemar Link GmbH & Co. KG (Mfg Site)
|
Total Knee Pack, REF CETJ130, medical convenience kits
|
3
|
06/15/2023
|
American Contract Systems, Inc.
|
Sterile custom surgical procedure packs:
(1) 89-10507.02, TOTAL KNEE PACK, Stonewall Jackson Hosp...
|
2
|
06/07/2023
|
DeRoyal Industries Inc
|
LINK SymphoKnee System L-Shaped Femoral Augment, Medial-Right/Lateral-Left, Sz 5-6
Tilastan, cement...
|
2
|
06/01/2023
|
Linkbio Corp.
|
Smith&Nephew ENGAGE Cementless Partial Knee System, Coated Tibial Insert, Part Numbers:
a) REF 1-...
|
2
|
05/31/2023
|
Smith & Nephew, Inc.
|
Smith&Nephew ENGAGE Cementless Partial Knee System, Coated Tibial Tray, Part Numbers: a) REF 1-1001...
|
2
|
05/31/2023
|
Smith & Nephew, Inc.
|
Smith&Nephew ENGAGE Cementless Partial Knee System, Tibial Anchor Stem, Part Numbers: a) REF 1-100...
|
2
|
05/31/2023
|
Smith & Nephew, Inc.
|
Smith&Nephew ENGAGE Cementless Partial Knee System, Porous Femoral components, Part Numbers:
a) ...
|
2
|
05/31/2023
|
Smith & Nephew, Inc.
|
TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM Intended for knee replacement
Catalog Number: 5532-...
|
2
|
05/30/2023
|
Howmedica Osteonics Corp.
|
TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM-Intended for knee replacement
Catalog Number: 5531-...
|
2
|
05/30/2023
|
Howmedica Osteonics Corp.
|
LINK SLED Knee System:
ENDO SLED KNEE FEM COMP, SMALL
Item Number: 15-2020/40
|
2
|
05/04/2023
|
Linkbio Corp.
|
LINK SLED Knee System:
ENDO SLED KNEE FEM COMP, MEDIUM SMALL
Item Number: 15-2020/46
|
2
|
05/04/2023
|
Linkbio Corp.
|
LINK SLED Knee System:
ENDO SLED KNEE FEM COMP, MEDIUM
Item Number: 15-2020/52
|
2
|
05/04/2023
|
Linkbio Corp.
|
LINK SLED Knee System:
ENDO SLED KNEE FEM COMP, Large
Item Number: 15-2020/60
|
2
|
05/04/2023
|
Linkbio Corp.
|
LINK SLED Knee System:
ALL POLY TIBIAL COMPONENT 7MM X 45MM
Item Number: 15-2028/01
|
2
|
05/04/2023
|
Linkbio Corp.
|
LINK SLED Knee System:
ALL POLY TIBIAL COMPONENT 9MM X 45MM
Item Number: 15-2028/02
|
2
|
05/04/2023
|
Linkbio Corp.
|
LINK SLED Knee System:
ALL POLY TIBIAL COMPONENT 11MM X 45MM
Item Number: 15-2028/03
|
2
|
05/04/2023
|
Linkbio Corp.
|
LINK SLED Knee System:
ALL POLY TIBIAL COMPONENT 13MM X 45MM
Item Number: 15-2028/04
|
2
|
05/04/2023
|
Linkbio Corp.
|
LINK SLED Knee System:
ALL POLY TIBIAL COMPONENT 7MM X 50MM
Item Number: 15-2028/05
|
2
|
05/04/2023
|
Linkbio Corp.
|
LINK SLED Knee System:
ALL POLY TIBIAL COMPONENT 9MM X 50MM
Item Number: 15-2028/06
|
2
|
05/04/2023
|
Linkbio Corp.
|
LINK SLED Knee System:
ALL POLY TIBIAL COMPONENT 11MM X 50MM
Item Number: 15-2028/07
|
2
|
05/04/2023
|
Linkbio Corp.
|
LINK SLED Knee System:
ALL POLY TIBIAL COMPONENT 13MM X 50MM
Item Number: 15-2028/08
|
2
|
05/04/2023
|
Linkbio Corp.
|
LINK SLED Knee System:
ALL POLY TIBIAL COMPONENT 7MM X 55MM
Item Number: 15-2028/09
|
2
|
05/04/2023
|
Linkbio Corp.
|
LINK SLED Knee System:
ALL POLY TIBIAL COMPONENT 9MM X 55MM
Item Number: 15-2028/10
|
2
|
05/04/2023
|
Linkbio Corp.
|
LINK SLED Knee System:
ALL POLY TIBIAL COMPONENT 11MM X 55MM
Item Number: 15-2028/11
|
2
|
05/04/2023
|
Linkbio Corp.
|
LINK SLED Knee System:
ALL POLY TIBIAL COMPONENT 13MM X 55MM
Item Number: 15-2028/12
|
2
|
05/04/2023
|
Linkbio Corp.
|
LINK SLED Knee System:
ALL POLY TIBIAL COMPONENT 7MM X 58MM
Item Number: 15-2028/13
|
2
|
05/04/2023
|
Linkbio Corp.
|
LINK SLED Knee System:
ALL POLY TIBIAL COMPONENT 9X58MM
Item Number: 15-2028/14
|
2
|
05/04/2023
|
Linkbio Corp.
|
LINK SLED Knee System:
ALL POLY TIBIAL COMPONENT 11X58MM
Item Number: 15-2028/15
|
2
|
05/04/2023
|
Linkbio Corp.
|
LINK SLED Knee System:
ALL POLY TIBIAL COMPONENT 13X58MM
Item Number: 15-2028/16
|
2
|
05/04/2023
|
Linkbio Corp.
|
LINK SLED Knee System:
ENDO MODEL SLED TIBIAL COMP 9 MM X 45 MM
Item Number: 15-2030/02
|
2
|
05/04/2023
|
Linkbio Corp.
|
LINK SLED Knee System:
ENDO MODEL SLED TIBIAL COMP 11 MM X 45 MM
Item Number: 15-2030/03
|
2
|
05/04/2023
|
Linkbio Corp.
|
LINK SLED Knee System
ENDO MODEL SLED TIBIAL COMP 13 MM X 45 MM
Item Number: 15-2030/04
|
2
|
05/04/2023
|
Linkbio Corp.
|
LINK SLED Knee System
ENDO MODEL SLED TIBIAL COMP 9 MM X 50 MM
Item Number: 15-2030/06
|
2
|
05/04/2023
|
Linkbio Corp.
|
LINK SLED Knee System
ENDO MODEL SLED TIBIAL COMP 11 MM X 50 MM
Item Number: 15-2030/07
|
2
|
05/04/2023
|
Linkbio Corp.
|
LINK SLED Knee System
ENDO MODEL SLED TIBIAL COMP 13 MM X 50 MM
Item Number: 15-2030/08
|
2
|
05/04/2023
|
Linkbio Corp.
|
LINK SLED Knee System
ENDO MODEL SLED TIBIAL COMP 9 MM X 55 MM
Item Number: 15-2030/10
|
2
|
05/04/2023
|
Linkbio Corp.
|
LINK SLED Knee System
ENDO MODEL SLED TIBIAL COMP 11 MM X 55 MM
Item Number: 15-2030/11
|
2
|
05/04/2023
|
Linkbio Corp.
|
LINK SLED Knee System
ENDO MODEL SLED TIBIAL COMP 13 MM X 55 MM
Item Number: 15-2030/12
|
2
|
05/04/2023
|
Linkbio Corp.
|