BEUDAMED
    39 results · 28ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Status: Terminated ×

    Tornier, LMP-50 (Lesser Metatarsal Phalangeal Implant), Size 50, Sterile EO, , Manufactured by Tornier, Inc, Edina, MN 55435. The Lesser Metatarsal Phalangeal Joint Implant is indicated for: Partial or complete dislocation of the lesser metatarsophalangeal joint.

    FDA Recall
    Terminated ·Tornier, Inc.·Product code KWH·April 6, 2009

    Latitude", Tige Humerale, Humeral Stem, Medium 77 mm, Humeral Stem Right, For Cemented use only, Sterile R, REF 0030402, Tornier In. Edina, MN 55435 USA. The Tornier In. Latitude Elbow Prosthesis is intended for total elbow arthroplasty. Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability following the effects of primary or secondary osteoarthritis and rheumatoid arthritis; correction of functional deformities; revision procedures where other treatments or devices have failed; treatment of fractures that are unmanageable using others techniques. The Tornier In. Latitude Elbow Prosthesis is intended for cemented use only.

    FDA Recall
    Terminated ·Tornier, Inc·Product code JDB·June 23, 2011

    Tornier Arthro Tunneler. For transossous fixation of tendons to bone in rotator cuff repair. Catalog Number: SMB000101

    FDA Recall
    Terminated ·TAG Medical Corp. Kibbutz Gaaton Naharia Israel·Product code NBH·December 4, 2009

    Aequalis Ascend Flex Shoulder System Reversed Platform (Reversed Tray component) Rx Only Sterile Manufacturer Tornier SAS - Saint Martin, France. Shoulder prosthesis component.

    FDA Recall
    Terminated ·Tornier, Inc·Product code KWS·May 28, 2021

    Fornier Phantom Fiber(TM) Sutures: Item Number Description SMB000425 4.5 MM PHANTOM FT BIOCOMPOSITE SUTURE ANCHOR WITH NEEDLES SMB000525 5.5 MM PHANTOM FT BIOCOMPOSITE SUTURE ANCHOR WITH NEEDLES SMP000425 4.5 MM PHANTOM FT PEEK SUTURE ANCHOR WITH NEEDLES SMP000525 5.5 MM PHANTOM FT PEEK SUTURE ANCHOR WITH NEEDLES SMSB0110 1PK PHANTOM FIBER SZ 2 WHITE SMSB0110N lPK BIOFIBER SUTURE SZ 2 WHT NEEDLED SMSB0112 10 PK PHANTOM FIBER SZ 2 WHITE SMSB0112N 10 PK PHANTOM FIBER SUTURE SZ 2WHT NEEDLED SMSB0120 1PK PHANTOM FIBER SZ 2 VIOLET SMSB0120N lPK BIOFIBER SUTURE SZ 2 VLT NEEDLED SMSB0122 10 PK PHANTOM FIBER SZ 2 VIOLET SMSB0122N 10 PK BIOFIBER SUTURE SZ 2 VLT NEEDLED SMSB0130 1PK PHANTOM FIBER SZ 2 WHITE/VIOLET SMSB0132 10 PK PHANTOM FIBER SZ 2 WHITE/VIOLET Indications for use for the Phantom Fiber are: Phantom Fiber suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.

    FDA Recall
    Terminated ·Tornier, Inc·Product code NWJ·February 8, 2018

    Aequalis Ascend Flex Humeral Stem: Part Number UDI DWF601A 3700386944475 DWF601B 3700386944482 DWF601C 3700386944499 DWF602A 3700386944505 DWF602B 3700386944512 DWF602C 3700386944529 DWF603A 3700386944536 DWF603B 3700386944543 DWF603C 3700386944550 DWF604A 3700386944567 DWF604B 3700386944574 DWF605A 3700386944598 DWF605B 3700386944604 DWF605C 3700386944611 DWF606A 3700386944628 DWF606B 3700386944635 DWF606C 3700386944642 DWF607A 3700386944659 DWF607B 3700386944666 DWF607C 3700386944673 DWF608A 3700386944680 DWF608B 3700386944697 DWF608C 3700386944703 DWF609A 3700386944710 DWF609B 3700386944727 DWF609C 3700386944734 DWF611A 3700386944741 DWF611B 3700386944758 DWF611C 3700386944765 DWF612A 3700386944772 DWF612B 3700386944789 DWF612C 3700386944796 DWF613A 3700386944802 DWF613B 3700386944819 DWF613C 3700386944826 DWF614A 3700386944833 DWF614B 3700386944840 DWF614C 3700386944857 DWF615A 3700386944864 DWF615B 3700386944871 DWF615C 3700386944888 DWF616A 3700386944895 DWF616B 3700386944901 DWF616C 3700386944918 DWF617A 3700386944925 DWF617B 3700386944932 DWF617C 3700386944949 DWF618A 3700386944956 DWF618B 3700386944963 DWF618C 3700386944970 DWF619A 3700386944987 DWF619B 3700386944994 DWF619C 3700386945007 DWF702A 3700386945045 DWF702B 3700386945052 DWF702C 3700386945069 DWF703A 3700386945076 DWF703B 3700386945083 DWF703C 3700386945090 DWF704A 3700386945106 DWF704B 3700386945113 DWF704C 3700386945120 DWF705A 3700386945137 DWF705B 3700386945144 DWF705C 3700386945151 DWF706A 3700386945168 DWF706B 3700386945175 DWF706C 3700386945182 DWF707A 3700386945199 DWF707B 3700386945205 DWF707C 3700386945212 DWF708A 3700386945229 DWF708B 3700386945236 DWF708C 3700386945243 DWF709A 3700386945250 DWF709B 3700386945267 DWF709C 3700386945274 DWF712A 3700386945311 DWF712B 3700386945328 DWF712C 3700386945335 DWF713A 3700386945342 DWF713B 3700386945359 DWF713C 3700386945366 DWF714A 3700386945373 DWF714B 3700386945380 DWF714C 3700386945397 DWF715A 3700386945403 DWF715B 3700386945410 DWF715C 3700386945427 DWF716A 3700386945434 DWF716B 3700386945441 DWF716C 3700386945458 DWF717A 3700386945465 DWF717B 3700386945472 DWF717C 3700386945489 DWF718A 3700386945496 DWF718B 3700386945502 DWF718C 3700386945519 DWF719A 3700386945526 DWF719B 3700386945533 DWF719C 3700386945540 Product Usage: The AEQUALIS ASCEND FLEX Convertible Shoulder System is intended for use as: A replacement of shoulder joints in primary anatomic or primary reverse. A replacement of other shoulder joint devices in case of revisions, if sufficient bone stock remains. The AEQUALIS ASCEND FLEX Convertible Shoulder System also allows for conversions from anatomic to reverse shoulder prosthesis in case of revision.

    FDA Recall
    Terminated ·Tornier, Inc·Product code PHX·October 18, 2019

    Salto Talaris Tibial Guide, Part # MJU333 ,Tray/Kit Code YKAL11, Non sterile. Orthopedic Manual Surgical Instrument

    FDA Recall
    Terminated ·Tornier, Inc·Product code HSN·August 6, 2015

    AEQUALIS HUMERAL NAIL DRILL BIT, REF 7020140 Product Usage: The Aequalis Humeral Nail system is intended to provide temporary stabilization of various types of proximal and/or diaphyseal fractures of the humerus. Types of fractures include, but are not limited to, non-unions, malunions, malalignments, pathological fractures, and impending pathological fractures. Examples of specific indications according to AO classification include Type A-Fractures, dislocated, Type B Fractures, dislocated, Type C-Fractures, with intact humeral head, or Humeral Fractures according to Neer-Classification (2, 3 and 4 part fractures).

    FDA Recall
    Terminated ·Tornier, Inc·Product code HTW·March 26, 2018

    AEQUALIS Reversed II or AEQUALIS Reversed Fracture Impactor. These products are contained within the Aequalis reversed II Instrument set tray no.YKAD83 and the Aequalis reversed fracture instrument set tray no.YKAD95. The items affected are MWD21, MWD023, MWD024 and MWD025. The impactor is an instrument used during shoulder arthroplasty; it is not implanted. The impactor is used to set the glenoid sphere, poly insert, spacer, and hemi adapter into place during surgery. The impactor is a two piece instrument which consists of a tip and a handle. The tip is made of plastic and metal that is pressed together for assembly.

    FDA Recall
    Terminated ·Tornier, Inc·Product code HTZ·August 13, 2013

    Aequalis Humeral Nail Targeting Jig, Product Code: 9020060. Orthopedic manual surgical instrument.

    FDA Recall
    Terminated ·Tornier, Inc·Product code HSB·June 25, 2015

    Aequalis Fx2 implant parts and instrument trays. Insert component : Part Numbers DWK204B-DWK206B, DWK224B-DWK226B, DWK230B-DWK23B, DWK244B-DWK246B, DWK250B-DWK252B, DWK264B-DWK266B, DWK270B-DWK272B. Stem Component: Part Number: DWK111B-DWK115B, DWK121B-DWK126B, DWK131B-DWK135B. Product Usage: Total or partial replacement of the Gleno-humeral articulation.

    FDA Recall
    Terminated ·Tornier, Inc·Product code KWS·September 19, 2016

    Fornier Phantom Fiber(TM) Sutures: Item Number Description SMB000425 4.5 MM PHANTOM FT BIOCOMPOSITE SUTURE ANCHOR WITH NEEDLES SMB000525 5.5 MM PHANTOM FT BIOCOMPOSITE SUTURE ANCHOR WITH NEEDLES SMP000425 4.5 MM PHANTOM FT PEEK SUTURE ANCHOR WITH NEEDLES SMP000525 5.5 MM PHANTOM FT PEEK SUTURE ANCHOR WITH NEEDLES SMSB0110 1PK PHANTOM FIBER SZ 2 WHITE SMSB0110N lPK BIOFIBER SUTURE SZ 2 WHT NEEDLED SMSB0112 10 PK PHANTOM FIBER SZ 2 WHITE SMSB0112N 10 PK PHANTOM FIBER SUTURE SZ 2WHT NEEDLED SMSB0120 1PK PHANTOM FIBER SZ 2 VIOLET SMSB0120N lPK BIOFIBER SUTURE SZ 2 VLT NEEDLED SMSB0122 10 PK PHANTOM FIBER SZ 2 VIOLET SMSB0122N 10 PK BIOFIBER SUTURE SZ 2 VLT NEEDLED SMSB0130 1PK PHANTOM FIBER SZ 2 WHITE/VIOLET SMSB0132 10 PK PHANTOM FIBER SZ 2 WHITE/VIOLET Indications for use for the Phantom Fiber are: Phantom Fiber suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.

    FDA Enforcement
    Class II ·Terminated·Tornier, Inc·April 25, 2018

    Aequalis Ascend Flex Shoulder System Reversed Platform (Reversed Tray component) Rx Only Sterile Manufacturer Tornier SAS - Saint Martin, France. Shoulder prosthesis component.

    FDA Enforcement
    Class II ·Terminated·Tornier, Inc·July 21, 2021

    AEQUALIS Reversed II or AEQUALIS Reversed Fracture Impactor. These products are contained within the Aequalis reversed II Instrument set tray no.YKAD83 and the Aequalis reversed fracture instrument set tray no.YKAD95. The items affected are MWD21, MWD023, MWD024 and MWD025. The impactor is an instrument used during shoulder arthroplasty; it is not implanted. The impactor is used to set the glenoid sphere, poly insert, spacer, and hemi adapter into place during surgery. The impactor is a two piece instrument which consists of a tip and a handle. The tip is made of plastic and metal that is pressed together for assembly.

    FDA Enforcement
    Class II ·Terminated·Tornier, Inc·September 25, 2013

    Salto Talaris Tibial Guide, Part # MJU333 ,Tray/Kit Code YKAL11, Non sterile. Orthopedic Manual Surgical Instrument

    FDA Enforcement
    Class II ·Terminated·Tornier, Inc·September 2, 2015

    Aequalis Humeral Nail Targeting Jig, Product Code: 9020060. Orthopedic manual surgical instrument.

    FDA Enforcement
    Class II ·Terminated·Tornier, Inc·August 5, 2015

    Aequalis Fx2 implant parts and instrument trays. Insert component : Part Numbers DWK204B-DWK206B, DWK224B-DWK226B, DWK230B-DWK23B, DWK244B-DWK246B, DWK250B-DWK252B, DWK264B-DWK266B, DWK270B-DWK272B. Stem Component: Part Number: DWK111B-DWK115B, DWK121B-DWK126B, DWK131B-DWK135B. Product Usage: Total or partial replacement of the Gleno-humeral articulation.

    FDA Enforcement
    Class II ·Terminated·Tornier, Inc·December 14, 2016

    AEQUALIS HUMERAL NAIL DRILL BIT, REF 7020140 Product Usage: The Aequalis Humeral Nail system is intended to provide temporary stabilization of various types of proximal and/or diaphyseal fractures of the humerus. Types of fractures include, but are not limited to, non-unions, malunions, malalignments, pathological fractures, and impending pathological fractures. Examples of specific indications according to AO classification include Type A-Fractures, dislocated, Type B Fractures, dislocated, Type C-Fractures, with intact humeral head, or Humeral Fractures according to Neer-Classification (2, 3 and 4 part fractures).

    FDA Enforcement
    Class II ·Terminated·Tornier, Inc·May 16, 2018

    Aequalis Ascend Flex Humeral Stem: Part Number UDI DWF601A 3700386944475 DWF601B 3700386944482 DWF601C 3700386944499 DWF602A 3700386944505 DWF602B 3700386944512 DWF602C 3700386944529 DWF603A 3700386944536 DWF603B 3700386944543 DWF603C 3700386944550 DWF604A 3700386944567 DWF604B 3700386944574 DWF605A 3700386944598 DWF605B 3700386944604 DWF605C 3700386944611 DWF606A 3700386944628 DWF606B 3700386944635 DWF606C 3700386944642 DWF607A 3700386944659 DWF607B 3700386944666 DWF607C 3700386944673 DWF608A 3700386944680 DWF608B 3700386944697 DWF608C 3700386944703 DWF609A 3700386944710 DWF609B 3700386944727 DWF609C 3700386944734 DWF611A 3700386944741 DWF611B 3700386944758 DWF611C 3700386944765 DWF612A 3700386944772 DWF612B 3700386944789 DWF612C 3700386944796 DWF613A 3700386944802 DWF613B 3700386944819 DWF613C 3700386944826 DWF614A 3700386944833 DWF614B 3700386944840 DWF614C 3700386944857 DWF615A 3700386944864 DWF615B 3700386944871 DWF615C 3700386944888 DWF616A 3700386944895 DWF616B 3700386944901 DWF616C 3700386944918 DWF617A 3700386944925 DWF617B 3700386944932 DWF617C 3700386944949 DWF618A 3700386944956 DWF618B 3700386944963 DWF618C 3700386944970 DWF619A 3700386944987 DWF619B 3700386944994 DWF619C 3700386945007 DWF702A 3700386945045 DWF702B 3700386945052 DWF702C 3700386945069 DWF703A 3700386945076 DWF703B 3700386945083 DWF703C 3700386945090 DWF704A 3700386945106 DWF704B 3700386945113 DWF704C 3700386945120 DWF705A 3700386945137 DWF705B 3700386945144 DWF705C 3700386945151 DWF706A 3700386945168 DWF706B 3700386945175 DWF706C 3700386945182 DWF707A 3700386945199 DWF707B 3700386945205 DWF707C 3700386945212 DWF708A 3700386945229 DWF708B 3700386945236 DWF708C 3700386945243 DWF709A 3700386945250 DWF709B 3700386945267 DWF709C 3700386945274 DWF712A 3700386945311 DWF712B 3700386945328 DWF712C 3700386945335 DWF713A 3700386945342 DWF713B 3700386945359 DWF713C 3700386945366 DWF714A 3700386945373 DWF714B 3700386945380 DWF714C 3700386945397 DWF715A 3700386945403 DWF715B 3700386945410 DWF715C 3700386945427 DWF716A 3700386945434 DWF716B 3700386945441 DWF716C 3700386945458 DWF717A 3700386945465 DWF717B 3700386945472 DWF717C 3700386945489 DWF718A 3700386945496 DWF718B 3700386945502 DWF718C 3700386945519 DWF719A 3700386945526 DWF719B 3700386945533 DWF719C 3700386945540 Product Usage: The AEQUALIS ASCEND FLEX Convertible Shoulder System is intended for use as: A replacement of shoulder joints in primary anatomic or primary reverse. A replacement of other shoulder joint devices in case of revisions, if sufficient bone stock remains. The AEQUALIS ASCEND FLEX Convertible Shoulder System also allows for conversions from anatomic to reverse shoulder prosthesis in case of revision.

    FDA Enforcement
    Class II ·Terminated·Tornier, Inc·November 20, 2019

    Tornier AFFINITI Humeral Head Standard 56mm x 21mm, Catalog No. 0020058. Sterile. Manufactured for Tornier, 10750 Cash Rd., Stafford, TX 77477. Tornier's Affiniti Shoulder System is a non-constrained glenohumeral prosthesis intended for use as a total or hemi-shoulder replacement system. The total shoulder consists of a metal humeral stem, a metal humeral head and an ultrahigh molecular weight polyethylene glenoid. The hemi-shoulder consists of a metal humeral stem and a metal humeral head.

    FDA Recall
    Terminated ·Tournier, Inc.·Product code KWS·October 20, 2008