BEUDAMED
    43 results · 57ms · Sources: EU EUDAMED, US FDA

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    Styker Orthobiologics Vita Plasma Separator, a component of Vitagel Surgical Hemostat. Sterile, single use device designed to prepare plasma from the patient's blood using a tabletop centrifuge.

    FDA Recall
    Terminated ·Stryker Orthobiologics, Inc.·Product code LMF·July 26, 2012

    Styker Orthobiologics Vita Plasma Separator, a component of Vitagel Surgical Hemostat. Sterile, single use device designed to prepare plasma from the patient's blood using a tabletop centrifuge.

    FDA Enforcement
    Class II ·Terminated·Stryker Orthobiologics, Inc.·November 28, 2012

    Vitagel; indicated in surgical procedures (other than in neurosurgical and ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.

    FDA Recall
    Terminated ·Orthovita, Inc., dBA Stryker Orthobiologics.·Product code LMH·February 26, 2015

    Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Catheter, 6", Part Number 2110-0503 Product Usage: Facilitate placement of bone cement in weakened or diminished bone

    FDA Recall
    Terminated ·Orthovita, Inc., dBA Stryker Orthobiologics.·Product code OAR·November 10, 2012

    Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Reamer, 8", Part Number 2110-0525 Product Usage: Facilitate placement of bone cement in weakened or diminished bone

    FDA Recall
    Terminated ·Orthovita, Inc., dBA Stryker Orthobiologics.·Product code OAR·November 10, 2012

    Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Catheter, 8", Part Number 2110-0526 Product Usage: Facilitate placement of bone cement in weakened or diminished bone

    FDA Recall
    Terminated ·Orthovita, Inc., dBA Stryker Orthobiologics.·Product code OAR·November 10, 2012

    Stryker Orthobiologics Imbibe Bone Marrow Aspiration Needle, Model Numbers: 2090-0027 Needle (bullet-tip), 11 gauge x 4 inch 2090-0028 Needle (bullet-tip), 11 gauge x 6 inch 2090-0029 Needle (bullet-tip), 8 gauge x 6 inch 2090-0047 Needle (bullet-tip), 8 gauge x 8 inch 2090-0030 Needle (bullet-tip), Fenestrated, 8 gauge x 6 inch intended for use to aspirate bone marrow or autologous blood.

    FDA Recall
    Terminated ·Orthovita, Inc., dBA Stryker Orthobiologics.·Product code KNW·December 4, 2014

    Stryker Orthobiologics Imbibe Aliquot Needle Bone Cement Needle- Model Numbers: 2110-0505 Beveled Needle, 11 gauge x 4 inch 2110-0524 Beveled Needle, 11 gauge x 6 inch 2110-0506 Diamond Needle, 11 gauge x 4 inch 2110-0529 Diamond Needle, 11 gauge x 6 inch Intended Use: Can be used in either direct (or open) and percutaneous (or deep) delivery of bone cement.

    FDA Recall
    Terminated ·Orthovita, Inc., dBA Stryker Orthobiologics.·Product code KNW·December 4, 2014

    Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Diamond Needle, 4", Part Number 2110-0506 Product Usage: Facilitate placement of bone cement in weakened or diminished bone

    FDA Recall
    Terminated ·Orthovita, Inc., dBA Stryker Orthobiologics.·Product code OAR·November 10, 2012

    Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Beveled Needle, 6", Part Number 2110-0524 Product Usage: Facilitate placement of bone cement in weakened or diminished bone

    FDA Recall
    Terminated ·Orthovita, Inc., dBA Stryker Orthobiologics.·Product code OAR·November 10, 2012

    Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger, 6", Part Number 2110-0501 Product Usage: Facilitate placement of bone cement in weakened or diminished bone

    FDA Recall
    Terminated ·Orthovita, Inc., dBA Stryker Orthobiologics.·Product code OAR·November 10, 2012

    Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger Delivery System, 4", Part Number 2090-0501 Product Usage: Facilitate placement of bone cement in weakened or diminished bone

    FDA Recall
    Terminated ·Orthovita, Inc., dBA Stryker Orthobiologics.·Product code OAR·November 10, 2012

    Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger, 8", Part Number 2110-0502 Product Usage: Facilitate placement of bone cement in weakened or diminished bone

    FDA Recall
    Terminated ·Orthovita, Inc., dBA Stryker Orthobiologics.·Product code OAR·November 10, 2012

    Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Beveled Needle, 4", Part Number 2110-0505 Product Usage: Facilitate placement of bone cement in weakened or diminished bone

    FDA Recall
    Terminated ·Orthovita, Inc., dBA Stryker Orthobiologics.·Product code OAR·November 10, 2012

    Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Reamer, 6", Part Number 2110-0504 Product Usage: Facilitate placement of bone cement in weakened or diminished bone

    FDA Recall
    Terminated ·Orthovita, Inc., dBA Stryker Orthobiologics.·Product code OAR·November 10, 2012

    Aliquot Delivery Kit (Syringe and Plunger); for use in open and percutaneous procedures to facilitate placement of bone cement in weakened or diminished bone

    FDA Recall
    Terminated ·Orthovita, Inc., dBA Stryker Orthobiologics.·Product code KIH·August 20, 2015

    Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger Delivery System, 6", Part Number 2090-0505 Product Usage: Facilitate placement of bone cement in weakened or diminished bone

    FDA Recall
    Terminated ·Orthovita, Inc., dBA Stryker Orthobiologics.·Product code OAR·November 10, 2012

    Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger Delivery System, 4", Part Number 2090-0502 Product Usage: Facilitate placement of bone cement in weakened or diminished bone

    FDA Recall
    Terminated ·Orthovita, Inc., dBA Stryker Orthobiologics.·Product code OAR·November 10, 2012

    Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Syringe Delivery System, 6", Part Number 2090-0504 Product Usage: Facilitate placement of bone cement in weakened or diminished bone

    FDA Recall
    Terminated ·Orthovita, Inc., dBA Stryker Orthobiologics.·Product code OAR·November 10, 2012

    Aliquot Delivery Kit (Syringe and Plunger); for use in open and percutaneous procedures to facilitate placement of bone cement in weakened or diminished bone

    FDA Enforcement
    Class II ·Terminated·Orthovita, Inc., dBA Stryker Orthobiologics.·September 23, 2015