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    OMNI Hip System, ApeX-LNK Acetabular Inserts 0 degree, 4+mm offset, Product Codes: H6-14436, H6-13928 & H6-14836 Product Usage: The Apex Hip System is intended for primary or revision total hip replacement. The femoral hip stems and acetabular cups are intended for uncemented fixation and single use implantation. The Apex Acetabular Cup liners, standard and ApeX-LNK Poly, are intended for use with the Apex Modular Acetabular Cup, in combination with the Apex Modular, Apex K2, Apex K2 mid length or Apex K1 Hip in total hip replacement procedures. The acetabular cup inserts are intended to articulate with a metal (cobalt chromium) or ceramic (alumina) femoral head. These prostheses may be used for the following conditions, as appropriate: Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis Rheumatoid arthritis Correction of functional deformity Congenital dislocation Revision procedures where other treatments or devices have failed

    FDA Recall
    Terminated ·OMNIlife science Inc.·Product code LPH·May 18, 2018

    OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component ApeX-LNK crosslinked Acetabular Insert, 10 deg hood; Product Code : H5-54840

    FDA Recall
    Terminated ·OMNIlife science Inc.·Product code LPH·July 23, 2019

    SERF Novae Dual Mobility Cup Insert 51/28- ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup for total hip replacement procedures. Product Code: H6-25128

    FDA Recall
    Terminated ·OMNIlife science Inc.·Product code LZO·December 21, 2020

    SERF Novae Dual Mobility Cup Insert 49/28-ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup for total hip replacement procedures. Product Code: H6-24928

    FDA Recall
    Terminated ·OMNIlife science Inc.·Product code LZO·December 21, 2020

    SERF Novae Dual Mobility Cup Insert 47/28- ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup for total hip replacement procedures. Product Code: H6-24728

    FDA Recall
    Terminated ·OMNIlife science Inc.·Product code LZO·December 21, 2020

    Evolut (TM) PRO System. With the following model numbers: a. EVOLUTPRO-23, Labeled as: VLV EVOLUTPRO-23 PRO COMM 29L OUS, VLV EVOLUTPRO-23 BLUE 29L COMM OUS, VLV EVOLUTPRO-23 BLUE COMM JPN, VLV EVOLUTPRO-23 BLUE 6L COMM OUS, VLV EVOLUTPRO-23 PRO COMM 29L CAN, VLV EVOLUTPRO-23 PRO COMM 29L OUS SA, VLV EVOLUTPRO-23 PRO COMM 29L AUS; b. EVOLUTPRO-23-US, Labeled as: VLV EVOLUTPRO-23-US BLUE COMM US, VLV EVOLUTPRO-23-US PRO BLNK US; c. EVOLUTPRO-26, Labeled as: VLV EVOLUTPRO-26 PRO COMM 29L OUS, VLV EVOLUTPRO-26 BLUE 6L COMM OUS, VLV EVOLUTPRO-26 PRO COMM 29L AUS, VLV EVOLUTPRO-26 BLUE COMM JPN, VLV EVOLUTPRO-26 BLUE 29L COMM OUS, VLV EVOLUTPRO-26 PRO COMM 29L CAN, VLV EVOLUTPRO-26 PRO COMM 29L OUS SA; d. EVOLUTPRO-26-US, Labeled as: VLV EVOLUTPRO-26-US BLUE COMM US, VLV EVOLUTPRO-26-US PRO BLNK US; e. EVOLUTPRO-29, Labeled as: VLV EVOLUTPRO-29 PRO COMM 29L OUS, VLV EVOLUTPRO-29 BLUE 29L COMM OUS, VLV EVOLUTPRO-29 BLUE 6L COMM OUS, VLV EVOLUTPRO-29 PRO COMM 29L AUS, VLV EVOLUTPRO-29 BLUE COMM JPN, VLV EVOLUTPRO-29 PRO COMM 29L CAN, VLV EVOLUTPRO-29 PRO COMM 29L OUS SA; f. EVOLUTPRO-29-US, Labeled as: VLV EVOLUTPRO-29-US BLUE COMM US, VLV EVOLUTPRO-29-US PRO BLNK US g. , Labeled as:

    FDA Recall
    Terminated ·Medtronic Heart Valves Division·Product code NPT·October 23, 2020

    Stryker Medical Stretcher Model 1037 Trauma A wheeled stretcher consists of a platform mounted on a wheeled frame that is designed to transport patients in a horizontal position. The device has siderails and supports for fluid infusion equipment.

    FDA Recall
    Terminated ·Stryker Medical Division of Stryker Corporation·Product code INK·July 19, 2011

    Stryker power cord kits, Stryker Medical, Portage, MI.

    FDA Recall
    Terminated ·Stryker Medical Div. of Stryker Corporation·Product code INK·March 19, 2010

    Dimension Assays: Uric Acid (URCA)

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code KNK·March 17, 2016

    1125 Prime Zoom Stryker Medical Stretcher A wheeled stretcher consists of a platform mounted on a wheeled frame that is designed to transport patients in a horizontal position. The device has siderails and supports for fluid infusion equipment.

    FDA Recall
    Terminated ·Stryker Medical Division of Stryker Corporation·Product code INK·July 19, 2011

    Uric Acid, Catalog No. OSR6x98 Product Usage:Uric acid OSR6x98 is intended as a System reagent for the quantitative determination of Uric Acid in human serum, heparinized plasma and urine on Beckman Coulter AU analyzers.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code KNK·April 13, 2016

    Advia Chemistry Assay: Uric Acid and Uric Acid, concentrated

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code KNK·March 17, 2016

    Stryker M-Series Stretcher, Model 1025 (SM304), Stryker Medical, Portage, MI.

    FDA Recall
    Terminated ·Stryker Medical Div. of Stryker Corporation·Product code INK·March 19, 2010

    Stryker Medical Stretcher Model 1105 Prime 5th Wheel A wheeled stretcher consists of a platform mounted on a wheeled frame that is designed to transport patients in a horizontal position. The device has siderails and supports for fluid infusion equipment.

    FDA Recall
    Terminated ·Stryker Medical Division of Stryker Corporation·Product code INK·July 19, 2011

    Stryker Medical Stretcher Model 1115 Prime Big Wheel A wheeled stretcher consists of a platform mounted on a wheeled frame that is designed to transport patients in a horizontal position. The device has siderails and supports for fluid infusion equipment.

    FDA Recall
    Terminated ·Stryker Medical Division of Stryker Corporation·Product code INK·July 19, 2011

    ABX PENTRA Uric Acid CP ref. A11A01670 is an in vitro diagnostic assay for the quantitative determination of uric acid in human serum, plasma and urine based on the enzymatic determination of uric acid using a chromogenic system in the presence of peroxidase and uricase (Trinder method).

    FDA Recall
    Terminated ·Horiba Instruments Inc·Product code KNK·January 11, 2016

    Pointe Scientific Uric Acid (Liquid) Reagent Set, Pointe Scientific, Inc., Canton, MI; Catalog # HU782-246 and HU982-615. For the quantitative determination of uric acid in serum on Hitachi analyzers. For in-vitro diagnostic use only.

    FDA Recall
    Terminated ·Pointe Scientific, Inc.·Product code KNK·December 1, 2009

    Stryker Renaissance Series Stretchers, Model 1231Z Emergency Care with Zoom, Stryker Medical, Portage, MI.

    FDA Recall
    Terminated ·Stryker Medical Div. of Stryker Corporation·Product code INK·March 19, 2010

    Beckman Coulter, Uric Acid Assay, Catalog No. OSR6X98

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code KNK·December 15, 2014

    VITROS Chemistry Products URIC Slides, REF/Product Code 194 3927 (300 slides per sales unit), Unique Device Identifier No. 10758750000340, Rx ONLY, IVD --- For in vitro diagnostic use only.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code KNK·August 11, 2016