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    Centrella Max - The Centrella Smart+ Bed is intended for use in healthcare environments as a patient support system to prevent and/or treat pressure injuries.Multiple model numbers of Centrella Max mattresses and pro+ mattresses. (1) Centrella Max Surface, REF P7922A01; (2) Centrella Max Surface, REF P7922A02; (3) Centrella Max Surface with X-Ray, REF P7922A03; (4) Centrella Max,Narrow, Rental, REF P7922ARENT01; (5) Centrella Pro+ 36" Surface with X-Ray, REF P7923A01; (6) Centrella Pro+ 40" Surface with X-Ray, REF P7923A02; (7) Centrella Pro+36" Surface, REF P7923A03; (8) Centrella Pro+ 40" Surface, REF P7923A04; (9) Pro+ MRS Surface for Hillrom 900 with X-Ray, REF P006800A01; (10) 80" MRS with X-Ray AU/NZ REF P006800A03; (11) Pro+ MRS Surface for Versacare with X-Ray, REF P3255A01; (12) Pro+ MRS Surface for Versacare, REF P3255A02; (13) Pro + MRS Surface for Versacare with X-Ray, REF P3255ARENT01; (14) Pro+ 36"MRS Surface with X-Ray, REF P7924A01; (15) Pro+ 40" MRS Surface with X-Ray, REF P7924A02; (16) Pro+ 36" MRS Surface, REF P7924A03; (17) Pro+ 40" MRS Surface, REF P7924A04; (18) Pro+ 36" MRS Rental Surface with X-Ray, REF P7924ARENT01.

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code IOQ·May 8, 2024

    Hill-Rom PRO+ 36" MRS Surface With X-Ray mattress, REF P7924A01; and REF P7924ARENT01, PRO+ MRS Rental Surface with X-Ray mattress.

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code IOQ·June 24, 2022

    Hill-Rom PRO+ 36" MRS Surface mattress, REF P7924A03.

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code IOQ·June 24, 2022

    Hill-Rom PRO+ MRS Surface For Versacare mattress, REF P3255A02.

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code IOQ·June 24, 2022

    Hill-Rom PRO+ MRS Surface For Versacare With X-Ray mattress, REF P3255A01.

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code IOQ·June 24, 2022

    Modular Replacement System (MRS) Cemented Stems, Sterile, Catalog Numbers: 6485-3-000, 6485-3-008, 6485-3-009, 6485-3-010, 6485-3-018, 6485-3-019, 6485-3-300, 6485-3-308, 6485-3-309, 6485-3-310, 6485-3-318, and 6485-3-319. The Modular Replacement System has been successfully used in clinical in clinical situations where there is extensive bone loss due to tumor resection, and/or failed previous prosthesis, or trauma. These components can be used to replace the proximal femur, the distal femur, the proximal tibia, or to reconstruct the total femur in extreme clinical situations.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code KRO·January 30, 2009

    Stryker Modular Replacement System Curved Cemented Stem; MRS 12mmx203 Femoral Stem. Catalog Number: 6485-3-313; Stryker Orthopaedics Mahwah, NJ 07430

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code JDI·November 15, 2007

    Stryker Modular Replacement System Curved Cemented Stem; MRS 11mmx203mm femoral stem. Catalog Number: 6485-3-311; Stryker Orthopaedics Mahwah, NJ 07430

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code JDI·November 15, 2007

    Stryker Modular Replacement System Curved Cemented Stem; MRS 15mmx203mm Femoral Stem. Catalog Number: 6485-3-315; Stryker Orthopaedics Mahwah, NJ 07430

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code JDI·November 15, 2007

    Stryker Modular Replacement System Curved Cemented Stem; MRS 17mmx203 Femoral Stem. Catalog Number 6485-3-317; Stryker Orthopaedics Mahwah, NJ 07430

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code JDI·November 15, 2007

    Stryker Modular Replacement System Curved Cemented Stem; MRS 11x127 Curved Femoral Stem. Catalog Number: 6485-3-711; Stryker Orthopaedics Mahwah, NJ 07430

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code JDI·November 15, 2007

    Stryker Modular Replacement System Curved Cemented Stem; MRS 15x127 Curved Femoral Stem. Catalog Number: 6485-3-715; Stryker Orthopaedics Mahwah, NJ 07430

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code JDI·November 15, 2007

    Stryker Modular Replacement System Curved Cemented Stem; MRS 17x127 Curved Femoral Stem. Catalog Number: 6485-3-717; Stryker Orthopaedics Mahwah, NJ 07430

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code JDI·November 15, 2007

    Stryker Modular Replacement System Curved Cemented Stem; MRS 13x127 Curved Femoral Stem. Catalog Number: 6485-3-713; Stryker Orthopaedics Mahwah, NJ 07430

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code JDI·November 15, 2007

    Stryker Modular Replacement System Curved Cemented Stem; MRS Small Curved Femoral Stem 8x102. Catalog Number 6485-3-308; Stryker Orthopaedics Mahwah, NJ 07430

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code JDI·November 15, 2007

    Stryker Modular Replacement System Curved Cemented Stem; MRS SM Curved Femoral Stem 10x102; Catalog Number: 6485-3-300; Stryker Orthopaedics Mahwah, NJ 07430

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code JDI·November 15, 2007

    Stryker Modular Replacement System Curved Cemented Stem; MRS Small Curved Femoral Stem 9 x 102. Catalog Number: 6485-3-309; Stryker Orthopaedics Mahwah, NJ 07430

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code JDI·November 15, 2007

    Hill-Rom PRO+ 36" MRS Surface, REF P7924A03, The pro+ mattress is intended for patient support and for the prevention and/or treatment of pressure injuries.

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code IOQ·March 5, 2024

    PTS Detect Cotinine, Ref. No. 3061, UPC 381933061017 in vitro diagnostic - Product Usage: The PTS Detect cotinine system provides quantitative measurement of the nicotine metabolite cotinine (25 200 ng/mL) in capillary (fingerstick) or venous whole blood. The test is for professional use to determine if an individual has been exposed to nicotine.

    FDA Recall
    Terminated ·Polymer Technology Systems, Inc.·Product code MRS·January 21, 2020

    GMRS Extension Piece, 60 mm; Sterile Stryker Howmedica Osteonics; Howmedica Internation S. de. R.L. Limerick, Ireland. The Global Modular Replacement System is intended to be used with the components of the Howmedica Osteonics Modular Replacement System , the Howmedica Osteonics Modular Rotating Hinge Knee System and/or the Howmedica Osteonics Kinematic Rotating Hinge Knee System in situations where replacement of extensive bone loss in the femur and/or proximal tibia is required. The Proximal Femoral Module and Distal Femoral Module of the GMR may be used together, or with the components of the MRS, in replacement of the total femur.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code KRO·May 5, 2005