BEUDAMED
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    The Optigun Ratchet is a hand-held cement gun for use with Optivac. The Optigun Ratchet is used to deliver bone cement from the Optivac.

    FDA Enforcement
    Class II ·Terminated·BIOMET FRANCE S.A.R.L.·June 17, 2015

    Endobon-Xenograft Granules, Zimmer Biomet, Synthetic Bone Grafting Material, used in dental and/or surgical procedures. Endobon Xenograft Granules, Bone Grafting Material, Synthetic are used in the following dental and/or surgical procedures: " Alveolar ridge augmentation/reconstruction, " Sinus elevation, " Filling of resection defects in benign bone tumor, bone cysts, or other defects in the alveolar ridge or wall, " Filling of bone defects after apicectomy, " Filling alveoli after tooth extraction. This product should not be used in non-peridontal mandibular applications.

    FDA Enforcement
    Class II ·Terminated·Biomet France SARL·February 17, 2016

    Biomet Microfixation outer packaging labeled in part:"REF: SP-2411***RUBBER BAND, LATEX FREE SMALL, HEAVY, 300/PACKAGE 4MM, (3/16" INNER DIAMETER) NON LATEX ELASTICS LOT 307850***DISTRIBUTED BY: BIOMET MICROFIXATION 1520 Tradeport Drive, Jacksonville, FL 32218 USA www.biometmicrofixation.com***." Inner Vendor/Manufacturer Label labeled in part:"H4 Elastics 4mm (3/16") Heavy 4 oz. REF 11-102-04***Manufactured for DENTSPLY GAC INTERNATIONAL DENTSPLY INTERNATIONAL, INC. Phone 631-419-1700 Fax 631-419-1599 355 Knickerbocker Avenue Bohemia NY 11716 USA***MediMark Europe BP2332 F-38033 Grenoble Cedex 2. France***LOT 82936-32 QTY:100 pk use by 2012-07 Made in USA ISSUED DATE 2009-04 GN***" Elastic bands used as elastomeric ties for ligation that facilitate treatment of fracture of the mandible and maxilla. They are commonly used with braces or arch bar wire.

    FDA Recall
    Terminated ·Biomet Microfixation, Inc.·Product code ECI·August 18, 2011

    Endobon-Xenograft Granules, Zimmer Biomet, Synthetic Bone Grafting Material, used in dental and/or surgical procedures. Endobon Xenograft Granules, Bone Grafting Material, Synthetic are used in the following dental and/or surgical procedures: " Alveolar ridge augmentation/reconstruction, " Sinus elevation, " Filling of resection defects in benign bone tumor, bone cysts, or other defects in the alveolar ridge or wall, " Filling of bone defects after apicectomy, " Filling alveoli after tooth extraction. This product should not be used in non-peridontal mandibular applications.

    FDA Recall
    Terminated ·Biomet France SARL Plateau de Lautagne Valence Cedex·Product code LYC·January 21, 2016

    The Optigun Ratchet is a hand-held cement gun for use with Optivac. The Optigun Ratchet is used to deliver bone cement from the Optivac.

    FDA Recall
    Terminated ·BIOMET FRANCE S.A.R.L. plateau de lautagne valence cedex·Product code KIH·May 14, 2015

    OPTICAL BIOMETER AL-Scan: Software Version: 1.09 and earlier. Ophthalmic: The OPTICAL BIOMETER AL-Scan is a measuring device that can measure as a single unit the values necessary to calculate the power of an IOL for cataract surgery such as axial length, corneal curvature radius, and anterior chamber depth. It measures these necessary values successively through a non-contact optical measurement method.

    FDA Enforcement
    Class II ·Terminated·Nidek Inc·August 24, 2016

    OPTICAL BIOMETER AL-Scan: Software Version: 1.09 and earlier. Ophthalmic: The OPTICAL BIOMETER AL-Scan is a measuring device that can measure as a single unit the values necessary to calculate the power of an IOL for cataract surgery such as axial length, corneal curvature radius, and anterior chamber depth. It measures these necessary values successively through a non-contact optical measurement method.

    FDA Recall
    Terminated ·Nidek Inc·Product code HJO·July 1, 2016

    Biomet Optigun Cement Gun, non-sterile; REF 419300 and REF 4193 (in Europe), Biomet, Inc., Warsaw, IN

    FDA Recall
    Terminated ·Biomet, Inc.·Product code LXH·September 21, 2007

    Biomet Optigun Cement Gun, Ratchet, non-sterile; REF 419500 and REF 4195 (in Europe), Biomet, Inc., Warsaw, IN

    FDA Recall
    Terminated ·Biomet, Inc.·Product code LXH·September 21, 2007

    PulsioFlex Monitoring System, Part Number: 6882747, Model Number: PC400 3 R0. Usage: The PulsioFlex Monitoring System is indicated in patients where cardiovascular and circulatory volume status monitoring is necessary. If a patient s biometric data are entered, the PulsioFlex Monitor presents the derived parameters indexed. ¿ -With the PiCCO Module cardiac output is determined both continuously through pulse contour analysis and intermittently through thermodilution technique. Both are used for the determination of other derived parameters. -With the CeVOX oximetry module connected to a compatible oximetry probe, the PulsioFlex Monitoring System measures continuous venous oxygen saturation to assess oxygen delivery and consumption. The use of the PulsioFlex Monitoring System is indicated in patients where cardiovascular and organ monitoring is useful. This includes patients in surgical, medical, and other hospital units

    FDA Enforcement
    Class II ·Terminated·GETINGE US SALES LLC·July 31, 2019

    Comprehensive Shoulder System, 4 mm, 122 mm long, Primary Shoulder Stem, Ti-6Al-4V, Standard Length Porous Plasma. Shoulder joint replacement components include humeral stems, humeral heads, and glenoid components.

    FDA Recall
    Terminated ·Biomet, Inc.·Product code MBF·April 16, 2015

    MCK Maximum Congruent Knee System, BIOMET FINNED PRI STEM 40MM; 80 x 10MM; 80 x 12.5 MM; 80 x 15 MM Knee joint replacement prostheses components include femoral, tibial, and patellar components.

    FDA Recall
    Terminated ·Biomet, Inc.·Product code JWH·April 16, 2015

    Mallory/Head Primary Hip System; Size 11, 160 mm, Lateralized Femoral Stem; Ti-6Al-4V; Porous Plasma Uncemented, & Mallory/Head Total Hip System Size 12, 165 mm, Bi- Metric Femoral Components. Hip joint replacement components include: femoral stems, femoral heads, acetabular shells, and acetabular liners.

    FDA Recall
    Terminated ·Biomet, Inc.·Product code LPH·April 16, 2015

    Biomet Cobalt-Chrome Femoral Components, 32MM MOD HEAD COCR -6MM NECK; 32MM MOD HEAD COCR -3 MM NECK; 32MM MOD HEAD COCR STD NECK ; 32MM MOD HEAD COCR +3MM NECK; 32MM COCR MOD HD +6MM NO SKIRT Hip joint replacement components include: femoral stems, femoral heads, acetabular shells, and acetabular liners.

    FDA Recall
    Terminated ·Biomet, Inc.·Product code JDI·April 16, 2015

    Biometric Combo Test Kit, Product K8500, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, blood specimen collection supplies and instructions. Blood specimen collection

    FDA Recall
    Terminated ·Heritage Labs International LLC·Product code JKA·January 9, 2011

    Nextra Hammertoe Correction System Driver SKU: NX-DR Orthopedic surgical instrument

    FDA Recall
    Terminated ·Nextremity Solutions·Product code HWC·February 10, 2022

    Nextra Hammertoe Correction System 3.5 Middle 3.2 Proximal Kit SKU: NX-3532K Orthopedic surgical instrument

    FDA Recall
    Terminated ·Nextremity Solutions·Product code HWC·February 10, 2022

    Nextra Hammertoe Correction System 4.5 Middle and 3.2 Proximal Saw Cut SKU: NX-4532K-SC Orthopedic surgical instrument

    FDA Recall
    Terminated ·Nextremity Solutions·Product code HWC·February 10, 2022

    Nextra Hammertoe Correction System 4.5 Middle 3.2 Proximal Kit SKU: NX-4532K Orthopedic surgical instrument

    FDA Recall
    Terminated ·Nextremity Solutions·Product code HWC·February 10, 2022

    Nextra Hammertoe Correction System 3.5 Middle and 3.2 Proximal Saw Cut SKU: NX-3532K-SC Orthopedic surgical instrument

    FDA Recall
    Terminated ·Nextremity Solutions·Product code HWC·February 10, 2022