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U.S. Department of Health and Human Services

Medical Device Recalls
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Product: kne
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Procedure packs: (1) Presource PBDS Cat. PN33BPCR2, Kit, Back, Sterile; (2) Presource PBDS Cat. POC... 2 10/10/2023 Cardinal Health 200, LLC
Zimmer Dermatome Blades- 10-pack boxes of blades. Intended for use with the dermatome handpiece whic... 2 10/06/2023 Zimmer Surgical Inc
Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Pr... 2 10/05/2023 Blue Belt Technologies, Inc
smith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, SIZE 5N, LEFT, NARROW, ... 2 09/20/2023 Smith & Nephew Inc
DJO Surgical: Empowr Knee, Universal Tibia Baseplate, 6R, REF: 352-02-106 2 09/19/2023 Encore Medical, LP
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)
The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging for... 2 08/24/2023 Medtronic Navigation, Inc.-Littleton
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the fo... 2 08/03/2023 MEDLINE INDUSTRIES, LP - Northfield
MRI Biomet Pin Guide for Total Knee Arthroplasty (Zimmer Biomet Patient Specific Instruments (PSI)--... 2 07/20/2023 Materialise N.V.
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) TOTAL JOIN... 2 07/20/2023 MEDLINE INDUSTRIES, LP - Northfield

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