• About the database
  • How to use the database
  • Download the data
  • FAQ
  • Credits
List view Cards view
  • Device 3026
  • Manufacturer 615
  • Event 124969
  • Implant 600
ABG II Modular Hip Stem
  • Model / Serial
    510 K092406  all lots  (4845-4XXX and NLS/NLV)
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution
  • Product Description
    ABG II Modular Hip Stem || Stryker Howmedica Osteonics Corp. Mahwah, NJ 07430 || Stryker Ireland Carrigtwohill Industrial Estate, Carrigtwohill County Cork, Ireland. || The ABG II Modular range of implants is constituted of 8 right stems and 8 left stems. The necks are made of GADS Vitallium, a proprietary Co Cr alloy that Stryker has developed. GADS stands for Gas Atomized Dispersion Strengthened. IT is a Co Cr alloy that is a corrosion resistant and demonstrates qualities of improved fatigue strength (with respect to regular Co Cr alloy). Neck Range - The ABG II modular neck range is composed of 10 reversible neck implants. There are different options in terms of length, version and neck angle. The AG II Modular necks come in two different lengths: 28 mm (short) and 36 mm (long). The necks are offered in two version angles ; 0 and 7. The 0 and 7 necks are available in 125, 130 and 135 neck angles.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.
  • 1 Event
    • Recall of ABG II Modular Hip Stem
ABGII modular Neck, Rejuvenate modular Neck, Rejuvenate modular Stem and ABGII modular Stem
  • Model / Serial
  • Implanted device?
    Yes
  • Product Description
    Implant
  • Manufacturer
    Stryker Ireland Ltd
  • 1 Event
    • Field Safety Notices about ABGII modular Neck, Rejuvenate modular Neck, Rejuvenate modular Stem and ABGII modular Stem
ABGII modular Stem, ABGII modular Neck, Rejuvenate modular Neck and Rejuvenate modular Stem
  • Model / Serial
  • Implanted device?
    Yes
  • Product Description
    Implant
  • Manufacturer
    Stryker Ireland Ltd
  • 1 Event
    • Field Safety Notices about ABGII modular Stem, ABGII modular Neck, Rejuvenate modular Neck and Rejuvenate modular Stem
ABGII modular Stems and ABGII modular Necks, Rejuvenate modular Stems and Rejuvenate modular Necks
  • Model / Serial
  • Implanted device?
    Yes
  • Product Description
    Implant - orthopedics
  • Manufacturer
    Stryker Ireland
  • 1 Event
    • Field Safety Notices about ABGII modular Stems and ABGII modular Necks, Rejuvenate modular Stems and Rejuvenate modular Necks
Accolade II 127 Neck Angle Hip Stem
  • Model / Serial
    510K K120578  Accolade II I27 Neck Angle Hip Stem, Size # 3 Catalog No.# 6721-0330 Lot Code #44416307  Accolade II 127 Neck Angle Hip Stem, Size #5 Catalog No. # 6721-0535 Lot Code 44564405
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution including states: AL, GA, IL, and WA.
  • Product Description
    1) Accolade II 127 Neck Angle Hip Stem, Size # 3 || 2) Accolade II 127 Neck Angle Hip Stem, Size #5 || Howmedica Osteonics Corp. || 325 Corporate Drive || Mahwah, NJ 07430 USA || Telephone # +1 201-831-5000 || Stryker France || ZAC Satolas Green Pusignan || Av de Satolas Green || 69881 MEYZIEU Cedex France || Intended for cementless application in total or hemiarthroplasty procedures.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.
  • 1 Event
    • Recall of Accolade II 127 Neck Angle Hip Stem
Accolade TMZF Plus Femoral Stem
  • Model / Serial
    Catalog Number: 6021-2530 Lot #40264005  Catalog Number: 6021-3535 Lot #40163005. This lot was not received in the US.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide distribution, including the states of NY, NJ, CA and FL.
  • Product Description
    Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #2.5 and Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #3.5, Howmedica Osteonics Corp. The intended use is for reconstruction of the head and neck of the femoral joint.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.
  • 1 Event
    • Recall of Accolade TMZF Plus Femoral Stem
all Remotion Radial implants
  • Model / Serial
  • Implanted device?
    Yes
  • Product Description
    Non-active implants - bone surgery
  • Manufacturer
    SBI
  • 1 Event
    • Field Safety Notices about all Remotion Radial implants
all rHead and uHead stem implants
  • Model / Serial
  • Implanted device?
    Yes
  • Product Description
    Non-active implants - bone surgery
  • Manufacturer
    SBI
  • 1 Event
    • Field Safety Notices about all rHead and uHead stem implants
Ankle Arthrodesis Nail / Proximal Humeral Nail
  • Model / Serial
  • Implanted device?
    Yes
  • Product Description
    Non-active implants - bone surgery
  • Manufacturer
    Stryker Trauma GmbH
  • 1 Event
    • Field Safety Notices about Ankle Arthrodesis Nail / Proximal Humeral Nail
a revision of surgical technique for Aviator
  • Model / Serial
  • Implanted device?
    Yes
  • Product Description
    Non-active implants - bone surgery
  • Manufacturer
    STRYKER
  • 1 Event
    • Field Safety Notices about a revision of surgical technique for Aviator
Bio ACL Screws, BioZip Anchors, XCEL Anchors
  • Model / Serial
  • Implanted device?
    Yes
  • Product Description
    Non-active implants - bone surgery
  • Manufacturer
    STRYKER
  • 1 Event
    • Field Safety Notices about Bio ACL Screws, BioZip Anchors, XCEL Anchors
carpal button screws
  • Model / Serial
  • Implanted device?
    Yes
  • Product Description
    Non-active implants
  • Manufacturer
    Small Bone Innovation International
  • 1 Event
    • Field Safety Notices about carpal button screws
CinchLock Flex Knotless Anchor with Inserter
  • Model / Serial
    Model number: CAT02643; Serial numbers: 15122202, 16011301,16020802
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed US (nationwide) and in Australia, Switzerland, Netherlands, Spain and Sweden.
  • Product Description
    CinchLock Flex Knotless Anchor with Inserter; || Model number CAT02643; || Orthopedic: || The Pivot CinchLock SS Knotless Anchor (CAT02462) and Pivot CinchLock Flex Knotless Anchor (CAT02463) are non-degradable implant devices intended for the fixation of soft tissue to bone. Used for repair of hip, shoulder, foot and ankle, elbow, wrist and hand and knee.
  • Manufacturer
    Stryker Corporation
  • 1 Event
    • Recall of CinchLock Flex Knotless Anchor with Inserter
CinchLock SS Knotless Anchor with Inserter
  • Model / Serial
    Model number: CAT02462 Serial numbers: 15120801, 15121401, 16010402, 16011901, 16012501.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed US (nationwide) and in Australia, Switzerland, Netherlands, Spain and Sweden.
  • Product Description
    CinchLock SS Knotless Anchor with Inserter; || Model number CAT02462; || Orthopedic: || The Pivot CinchLock SS Knotless Anchor (CAT02462) and Pivot CinchLock Flex Knotless Anchor (CAT02463) are non-degradable implant devices intended for the fixation of soft tissue to bone. Used for repair of hip, shoulder, foot and ankle, elbow, wrist and hand and knee.
  • Manufacturer
    Stryker Corporation
  • 1 Event
    • Recall of CinchLock SS Knotless Anchor with Inserter
CinchLock SS Knot Less Anchor with introducer
  • Model / Serial
  • Implanted device?
    Yes
  • Product Description
    Implant
  • Manufacturer
    Stryker Endoscopy
  • 1 Event
    • Field Safety Notices about CinchLock SS Knot Less Anchor with introducer
Citation AT Femoral Stem
  • Model / Serial
    Catalog #-- Description-- # of lots:  6265-2-102, Citation AT Left Hip Stem #2, 11 lots; 6265-2-103, Citation AT Left Hip Stem #3, 15 lots; 6265-2-104, Citation AT Left Hip Stem #4, 31 lots; 6265-2-105, Citaiton AT Left Hip Stem #5, 31 lots; 6265-2-112, Citation AT Left Hip Stem #2, 1 lot # P4GFD; 6265-2-113, Citation AT Left Hip Stem #3, 49 lots; 6265-2-114, Citation AT Left Hip Stem #4 , 27 lots; 6265-2-115, Citation AT Left Hip Stem #5, 23 lots.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    nationwide
  • Product Description
    Citation AT Femoral Stem
  • Manufacturer
    Stryker Howmedica Osteonics Corp.
  • 1 Event
    • Recall of Citation AT Femoral Stem
CMI@ - Collagen Meniscus lmplant
  • Model / Serial
  • Implanted device?
    Yes
  • Product Description
    Non-active implants - bone surgery
  • Manufacturer
    Ivy Sports Medicine
  • 1 Event
    • Field Safety Notices about CMI@ - Collagen Meniscus lmplant
Definition PM COCR hip stem
  • Model / Serial
  • Implanted device?
    Yes
  • Product Description
    Implant - orthopedics
  • Manufacturer
    Stryker Orthopaedics
  • 1 Event
    • Field Safety Notices about Definition PM COCR hip stem
Device Recall 1,2,7,8 TGC Upper Tray
  • Model / Serial
    Catalog Numbers: 6543-8-014, 6543-8-015.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -- US and Canada.
  • Product Description
    Triathlon Revision Instruments; 1,2,7,8 TGC Upper Tray; Non Sterile, || Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430. || For total knee arthroplasty procedures involving Triathlon Total Stabilizer components. The trays sterilize and transport instruments needed for such procedures.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.
  • 1 Event
    • Recall of Device Recall 1,2,7,8 TGC Upper Tray
Device Recall 36 TCG Upper Tray
  • Model / Serial
    Catalog Number: 6543-8-014.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -- US and Canada.
  • Product Description
    Triathlon Revision Instruments, 3-6 TCG Upper Tray; Non Sterile; || Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430. || For total knee arthroplasty procedures involving Triathlon Total Stabilizer components. The trays sterilize and transport instruments needed for such procedures.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.
  • 1 Event
    • Recall of Device Recall 36 TCG Upper Tray
Device Recall 6.5 Cancellous Bone Screw 25 mm
  • Model / Serial
    Lot Code: 35323605
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    nationwide
  • Product Description
    6.5 Cancellous Bone Screw 25 mm; Responsible Firm on Label: Manufacturer, Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 USA, A Subsidiary of Stryker Corp., Made in USA; Catalog Number: 2030-6525-1 || The Omnifit bone screws are intended to augment the fixation of compatible acetabular cups.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.
  • 1 Event
    • Recall of Device Recall 6.5 Cancellous Bone Screw 25 mm
Device Recall Accolade and Restoration hip product
  • Model / Serial
    Lot: 56211103, 56211401, 56211704, 57284004
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed in ten (10) states: AR, DE, FL, IL, IN, MI, NJ, OH, TN, and TX; and Canada, Sweden, United Kingdom, France, Spain, Italy, Japan, Romania, Colombia, Netherlands, and Australia.
  • Product Description
    Accolade and Restoration hip product; Catalog Number: 6720-0837 and 6721-0737
  • Manufacturer
    Howmedica Osteonics Corp.
  • 1 Event
    • Recall of Device Recall Accolade and Restoration hip product
Device Recall Accolade and Restoration hip product
  • Model / Serial
    Lot: 55624702, 55709001, 55709002, 55709003, 55959003, 55967305, 56011203, 56011205, 56011301, 56019501, and 56109304
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed in ten (10) states: AR, DE, FL, IL, IN, MI, NJ, OH, TN, and TX; and Canada, Sweden, United Kingdom, France, Spain, Italy, Japan, Romania, Colombia, Netherlands, and Australia.
  • Product Description
    Accolade and Restoration hip product; Catalog Number: 6021-0030, 6276-1-127, 6276-5-216, 6020-2530, 6020-4535, 6021-0740, 6021-0230, and 6021-4535
  • Manufacturer
    Howmedica Osteonics Corp.
  • 1 Event
    • Recall of Device Recall Accolade and Restoration hip product
Device Recall Accolade C CS
  • Model / Serial
    6057-0335D ACCOLADE C CS 127 NK JYLMME,  6057-0537D ACCOLADE C CS 127 NK JYNMME,  6057-0740D ACCOLADE C CS 127 NK E5EMME and 6058-0335D ACCOLADE C CS 132 NK JYVMME
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide. OUS: Australia, Canada, Japan, Argentina, Brazil, Germany, Spain, Columbia, Guatemala and Sweden.
  • Product Description
    Accolade C CS || These devices are modular components of a total hip system. These femoral stems are intended for use with femoral heads and acetabular components in primary or revision total hip arthroplasty.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.
  • 1 Event
    • Recall of Device Recall Accolade C CS
Device Recall Accolade Distal Spacer
  • Model / Serial
    Catalog No.: 1059-6714 Lot Code: WDYMLE
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide distribution.
  • Product Description
    Stryker Orthopaedics, Accolade Distal Centralizer 14 mm Large; Catalog No.: 1059-6714. For use with Accolade hip prosthesis.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.
  • 1 Event
    • Recall of Device Recall Accolade Distal Spacer
  • 1
  • 2
  • 3
  • …
  • Next ›
  • Last »

About this database

Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers.

  • FAQ
  • About the database
  • Contact us
  • Credits

Stories in your inbox

Do you work in the medical industry? Or have experience with a medical device? Our reporting is not done yet. We want to hear from you.

Tell us your story!

Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

Download the data

The International Medical Devices Database is licensed under the Open Database License and its contents under Creative Commons Attribution-ShareAlike license. Always cite the International Consortium of Investigative Journalists when using this data. You can download a raw copy of the database here.

Download all (zipped)