BEUDAMED
    56 results · 12ms · Sources: EU EUDAMED, US FDA

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    Zimmer M/DN Intramedullary Fixation 5.5 dia. cortical screw, 3.5 mm hex head, 70 mm length, 22-13-5 stainless steel, sterile bone screw; Cat. no. 2253-70-55 (00225307055).

    FDA Recall
    Terminated ·Zimmer Inc.·Product code NDJ·June 26, 2006

    INTERLOCKING IM SCREW 4.5 and INTERLOCKING IM SCREW LG Some items starting with codes 0022530

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code NDJ·October 11, 2013

    Package of cross-drive bone screws labeled in part: "***REF #95-1504***"1.5MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW, 5/ PK***1.5 X4MM TITANIUM***CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN***BIOMET MICROFIXATION***1520 TRADEPORT DRIVE***JACKSONVILLE, FL 32218 USA***www.biometmicrofixation.com***" "***REF: 91-1504***"1.5MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW***1.5 X4MM TITANIUM***CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN.***BIOMET MICROFIXATION***1520 TRADEPORT DRIVE***JACKSONVILLE, FL 32218 USA***www.biometmicrofixation.com***" Products subject to recall: REF #95-1504***"1.5MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW, 5/ PK, Lot 622120. REF: 91-1504***"1.5MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW, 1/PK, Lot 622120. Internal fixation screw intended to aid in the alignment and stabilization of bone in the oral cranio-maxillofacial skeletal system.

    FDA Recall
    Terminated ·Biomet Microfixation, Inc.·Product code NDJ·November 8, 2010

    Zimmer M/DN Intramedullary Fixation 5.5 dia. cortical screw, 3.5 mm hex head, 95 mm length, 22-13-5 stainless steel, sterile bone screw; Cat. no. 2253-95-55 (00225309555).

    FDA Recall
    Terminated ·Zimmer Inc.·Product code NDJ·June 26, 2006

    Zimmer M/DN Intramedullary Fixation 5.5 dia. cortical screw, 3.5 mm hex head, 100 mm length, 22-13-5 stainless steel, sterile bone screw; Cat. no. 2253-100-55 (00225310055).

    FDA Recall
    Terminated ·Zimmer Inc.·Product code NDJ·June 26, 2006

    Zimmer M/DN Intramedullary Fixation 4.2 dia. cortical screw, 3.5 mm hex head, 75 mm length, 22-13-5 stainless steel, sterile bone screw; Cat. no. 2253-75-42 (00225307542).

    FDA Recall
    Terminated ·Zimmer Inc.·Product code NDJ·June 26, 2006

    Zimmer M/DN Intramedullary Fixation 4.2 dia. cortical screw, 3.5 mm hex head, 85 mm length, 22-13-5 stainless steel, sterile bone screw; Cat. no. 2253-85-42 (00225308542).

    FDA Recall
    Terminated ·Zimmer Inc.·Product code NDJ·June 26, 2006

    Cortical Screw for M/DN Intramedullary Fixation. Metaphyseal/Diaphyseal Nail System, Orthopedic surgical device.

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code NDJ·April 29, 2015

    Zimmer M/DN Intramedullary Fixation 4.5 dia. cortical screw, 3.5 mm hex head, 65 mm length, 22-13-5 stainless steel, sterile bone screw; Cat. no. 2253-65-45 (00225306545).

    FDA Recall
    Terminated ·Zimmer Inc.·Product code NDJ·June 26, 2006

    Package of center-drive bone screws labeled in part: "***REF: 01-7204***1.5MM" SYSTEM CENTER-DRIVE SCREW, 5/ PKG***1.5 X4MM TITANIUM***CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN.***BIOMET MICROFIXATION***1520 TRADEPORT DRIVE***JACKSONVILLE, FL 32218 USA***www.biometmicrofixation.com***" "***REF: 99-7204***"1.5MM" SYSTEM CENTER-DRIVE SCREW, 1/ PKG***1.5 X4MM TITANIUM***CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN.***BIOMET MICROFIXATION***1520 TRADEPORT DRIVE***JACKSONVILLE, FL 32218 USA***www.biometmicrofixation.com***" REF: 01-7204 1.5MM" SYSTEM CENTER-DRIVE SCREW, 5/ PKG, Lot 202450. REF: 99-7204 "1.5MM" SYSTEM CENTER-DRIVE SCREW, 1/ PKG, Lot 202450. Internal fixation screw intended to aid in the alignment and stabilization of bone in the oral cranio-maxillofacial skeletal system.

    FDA Recall
    Terminated ·Biomet Microfixation, Inc.·Product code NDJ·November 8, 2010

    Zimmer M/DN Intramedullary Fixation 4.2 dia. cortical screw, 3.5 mm hex head, 70 mm length, 22-13-5 stainless steel, sterile bone screw; Cat. no. 2253-70-42 (00225307042).

    FDA Recall
    Terminated ·Zimmer Inc.·Product code NDJ·June 26, 2006

    Zimmer M/DN Intramedullary Fixation 4.5 dia. cortical screw, 3.5 mm hex head, 52.5 mm length, 22-13-5 stainless steel, sterile bone screw; Cat. no. 2253-53-45 (00225305345).

    FDA Recall
    Terminated ·Zimmer Inc.·Product code NDJ·June 26, 2006

    Zimmer M/DN Intramedullary Fixation 4.5 dia. cortical screw, 3.5 mm hex head, 55 mm length, 22-13-5 stainless steel, sterile bone screw; Cat. no. 2253-55-45 (00225305545).

    FDA Recall
    Terminated ·Zimmer Inc.·Product code NDJ·June 26, 2006

    KY SENSITIVE TM JELLY Personal Lubricant. The product is packaged into 3 oz tubes, which are then packed into a printed carton. Distributed by McNeil-PPC Inc.

    FDA Recall
    Terminated ·Mc-NEIL-PPC, Inc.·Product code NUC·January 25, 2013

    KY TINGLING JELLY Personal Lubricant. The product is packaged into 5 oz tubes with the UPC printed on it. Distributed By: McNeil-PPC Inc.

    FDA Recall
    Terminated ·Mc-NEIL-PPC, Inc.·Product code NUC·January 25, 2013

    KY SilkE Vaginal Moisturizer and Personal Lubricant. The product is packaged in 2.5 oz bottles, which are then packed into a printed carton. Distributed by McNeil-PPC Inc.

    FDA Recall
    Terminated ·Mc-NEIL-PPC, Inc.·Product code NUC·January 25, 2013

    G1 Dissection Tool - 6MM CRS DBALL, 2mm Shaft EXP, M; For cutting and shaping bone including spine and cranium.

    FDA Enforcement
    Class II ·Terminated·The Anspach Effort, Inc.·September 28, 2016

    Depuy Mitek Fastin RC Anchor with Panacryl (2) strands Size 2 Panacryl Poly ***braided absorbable suture Reference Number: 222740

    FDA Recall
    Terminated ·Depuy Mitek, a Johnson & Johnson Co.·Product code MAI·October 27, 2005

    Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1. Intended for in vivo imaging.

    FDA Enforcement
    Class III ·Terminated·Optovue, Inc.·June 12, 2013

    CIVCO Arm Support, REF 106047, distributed as: (a) Rigid Arm Support, Large, Set, Red (PN: 106047) (b) PB2-BDLRL (PN: 109040) (c) Rigid Adj. Arm Support, Large, Set (PN: 106048) (d) PSR2-CF-DLRL-2P Posirest-2 (PN: 106522) The Rigid Arm Supports are utilized on the Posibboard2 and Posirest assemblies, which are intended to position the patients upper extremities during breast and lung diagnostic and radiotherapy treatment.

    FDA Enforcement
    Class II ·Terminated·Med Tec Inc·September 6, 2017