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    Bigliani/Flatow The Complete Shoulder Solution Trabecular Metal Glenoid Instrument Drill with Stop, 6 mm; the products are medical instruments intended for use when performing surgery of the shoulder.

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code KWT·May 12, 2012

    Zimmer Trabecular Metal Reverse Shoulder System Surgical Technique. Catalog Number 97-4309-003-00, Rev. 4. The Zimmer Trabecular Metal Reverse Shoulder System is a treatment option for patients with severe rotator cuff (RC) deficiency. The stem was designed so that its bearing surfaces, as compared to a traditional humeral stem, is such that the humeral component contains a concave ultra-high molecular weight polyethylene (UHMWPE) liner that articulates with a hemispheric metallic glenoid component. System is used for: -the treatment of severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint; - ununited humeral head fractures of long duration; - irreducible 3-and 4-part proximal humeral fractures; - avascular necrosis of the humeral head, or other difficult clinical management problems where arthrodesis or resectional arthroplasty is not acceptable.

    FDA Recall
    Terminated ·Zimmer Inc.·Product code KWT·September 10, 2010

    Zimmer Trabecular Metal Reverse Shoulder System Glenosphere, 36 mm diameter; Catalog/Ref No. 00-4349-036-01.

    FDA Recall
    Terminated ·Zimmer Inc.·Product code KWT·July 20, 2006

    Bio-Modular Humeral Head 48mm x 24mm Ti 6AI4V/Ion Implanted (Orthopedic Implant) Product Usage: The OSS Knee Reamer Sleeves are primarily used to guide the bullet tip of cylindrical reamers during the tibial preparation in OSS procedures. They are reusable.

    FDA Recall
    Terminated ·Biomet, Inc.·Product code KWT·November 1, 2012

    Trabecular Metal Reverse Shoulder System, Item Nos. 00434210613 00430900103 00434210613 00434210813 00434210817 00434210913 00434211013 00434211017 00434211113 00434211213 00434211217 00434211313 00434211413 00434211417 00434211513 00434211613 00434211713 00434211813 00434810613 00434810813 00434810817 00434810913 00434811013 00434811017 00434811113 00434811213 00434811217 00434811313 00434811413 00434811417 00434811513 00434811613 00434811713 00434811813 00434900813 00434900817 00434901013 00434901017 00434901213 00434901217 00434901413 00434903700 00434903811 00434903909 00434903912 32855090339 32855090353 32855090368 32855090375 32855090395 32855090512 32855090519 32855090520 32855090531 32855090585 32855090593 32855090598 32855090599 32855090628 32855090636 32855090637 32855090640 32855090658 32855090659 32855090734 47430703100 47430704100 47430706100

    FDA Recall
    Terminated ·Zimmer Biomet, Inc.·Product code KWT·October 10, 2019

    Zimmer Trabecular Metal Reverse Shoulder System Base Plate; Catalog/Ref No. 00-4349-038-00.

    FDA Recall
    Terminated ·Zimmer Inc.·Product code KWT·July 20, 2006

    Zimmer Trabecular Metal Humeral Stem Surgical Technique. Catalog Number: 97-4309-002-00, Rev. 3 The Zimmer Trabecular Metal Shoulder System consists of conventional and reverse, semi- and nonconstrained (resurfacing) shoulder prostheses for total or hemi-arthroplasty applications. System is used for: -the treatment of severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint; - ununited humeral head fractures of long duration; - irreducible 3-and 4-part proximal humeral fractures; - avascular necrosis of the humeral head, or other difficult clinical management problems where arthrodesis or resectional arthroplasty is not acceptable.

    FDA Recall
    Terminated ·Zimmer Inc.·Product code KWT·September 10, 2010

    Trabecular Metal" Reverse Shoulder System

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code KWT·October 17, 2013

    ZIMMER TRABECULAR METAL SHOULDER INSTRUMENTATION, DISTAL PILOT used for implantation of the Zimmer Trabecular Metal Humeral and/or Zimmer Trabecular Metal Reverse Shoulder Systems: Catalog Number 00-4310-008/018-13. The distal pilot manual surgical instrument is used in the surgical procedure to implant the Zimmer Trabecular Metal Humeral and Zimmer Trabecular Metal Reverse Shoulder Systems. The distal pilot is attached to the proximal reamer during proximal reaming and to the proximal provisional during trialing. In both of these cases the distal pilot is used to provide alignment for the proximal devices. The Zimmer Trabecular Metal Shoulder System consists of conventional and reverse, semi- and nonconstrained (resurfacing) shoulder prostheses for total or hemi-arthroplasty applications. The Zimmer Trabecular Metal Reverse Shoulder System is a treatment option for patients with severe rotator cuff (RC) deficiency. The stem was designed so that its bearing surfaces, as compared to a traditional humeral stem, is such that the humeral component contains a concave ultra-high molecular weight polyethylene (UHMWPE) liner that articulates with a hemispheric metallic glenoid component. These two systems are used for: - the treatment of severe pain or significant disability in degenerative, - rheumatoid, or traumatic disease of the glenohumeral joint; - ununited humeral head fractures of long duration; - irreducible 3-and 4-part proximal humeral fractures; - avascular necrosis of the humeral head, or other difficult clinical management problems where arthrodesis or resectional arthroplasty is not acceptable.

    FDA Recall
    Terminated ·Zimmer Inc.·Product code KWT·September 10, 2010

    Zimmer Trabecular Metal Humeral Stem 4-Part Fracture Surgical Technique. Catalog Number 97-4309-004-00, Rev. 3. The Zimmer Trabecular Metal Shoulder System consists of conventional and reverse, semi- and nonconstrained (resurfacing) shoulder prostheses for total or hemi-arthroplasty applications. System is used for: -the treatment of severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint; - ununited humeral head fractures of long duration; - irreducible 3-and 4-part proximal humeral fractures; - avascular necrosis of the humeral head, or other difficult clinical management problems where arthrodesis or resectional arthroplasty is not acceptable

    FDA Recall
    Terminated ·Zimmer Inc.·Product code KWT·September 10, 2010

    Equinoxe Reverse Glenosphere Locking Screw Intended for Primary and Reverse Total Shoulder Arthroplasty.

    FDA Recall
    Terminated ·Exactech, Inc.·Product code KWT·June 15, 2012

    00 4309-049-00 Trabecular Metal Reverse Shoulder Glenosphere Distractor Rx, Non sterile (sterilize before use) The Glenosphere Distractor must be able to attach, connect, or mate with the Glenosphere and remove it without dislodging or loosening the base plate from the glenoid, or damaging the glenoid. Pulling the trigger releases a weight inside the Distractor. This force is transmitted to the bottom of the glenosphere dislodging it from the base plate.

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code KWT·August 1, 2013

    Zimmer Trabecular Metal Reverse Shoulder System Glenosphere, 40 mm diameter; Catalog/Ref No. 00-4349-040-01.

    FDA Recall
    Terminated ·Zimmer Inc.·Product code KWT·July 20, 2006

    Various Custom Devices, Item Nos. 32855090246 32855090252 32855090256 32855090265 32855090266 32855090270 32855090287 32855090290 32855090291 32855090297 32855090302 32855090317 32855090318 32855090319 32855090327 32855090329 32855090334 32855090336 32855090339 32855090348 32855090351 32855090352 32855090353 32855090354 32855090368 32855090369 32855090375 32855090376 32855090395 32855090396 32855090402 32855090409 32855090414 32855090434 32855090437 32855090439 32855090448 32855090450 32855090465 32855090484 32855090496 32855090497 32855090498 32855090501 32855090507 32855090512 32855090519 32855090520 32855090531 32855090543 32855090576 32855090585 32855090586 32855090593 32855090598 32855090599 32855090609 32855090615 32855090622 32855090628 32855090636 32855090637 32855090638 32855090640 32855090658 32855090659 32855090661 32855090715 32855090734 32855510763 32855510796 32855510797 32855510799 32855510800 32855510801 32855510805 32855510808 32855510822 32855510843 32855510844 32855140373 32855411710 32855430479 32855430480 32855430496 32855430498 32855430519 32855430529 32855430533 32855430535 32855430542 32855430544 32855430582 32855430588 32855450430 32855450439 32855450471 32855450483 32855450525 32855470651 32855470715 32855470793 32855470795 32855470796 32855470866 32855470920 32855470921 32855470923 32855480803 32855480808 32855480823 32855480824 32855480828 32855480829 32855480945 32855480963 32855480990 32855481016 32855910440 32855910454 32855910455 32855910456 32855910475 32855910485 32873400307

    FDA Recall
    Terminated ·Zimmer Biomet, Inc.·Product code KWT·October 10, 2019

    Equinoxe Reverse Shoulder Fixed Angle Torque Defining Screw Kit

    FDA Recall
    Terminated ·Exactech, Inc.·Product code KWT·October 25, 2016

    COMP 12MM HUM FRAC STEM MACRO, model # 11-113562

    FDA Recall
    Terminated ·Zimmer Biomet, Inc.·Product code KWT·June 5, 2017

    ZIMMER TRABECULAR METAL" SHOULDER INSTRUMENTATION, DISTAL PILOT used for implantation of the Zimmer Trabecular Metal Humeral and/or Zimmer Trabecular Metal Reverse Shoulder Systems: Catalog Number 00-4310-008/014-17. The distal pilot manual surgical instrument is used in the surgical procedure to implant the Zimmer Trabecular Metal Humeral and Zimmer Trabecular Metal Reverse Shoulder Systems. The distal pilot is attached to the proximal reamer during proximal reaming and to the proximal provisional during trialing. In both of these cases the distal pilot is used to provide alignment for the proximal devices. The Zimmer Trabecular Metal Shoulder System consists of conventional and reverse, semi- and nonconstrained (resurfacing) shoulder prostheses for total or hemi-arthroplasty applications. The Zimmer Trabecular Metal Reverse Shoulder System is a treatment option for patients with severe rotator cuff (RC) deficiency. The stem was designed so that its bearing surfaces, as compared to a traditional humeral stem, is such that the humeral component contains a concave ultra-high molecular weight polyethylene (UHMWPE) liner that articulates with a hemispheric metallic glenoid component. These two systems are used for: - the treatment of severe pain or significant disability in degenerative, - rheumatoid, or traumatic disease of the glenohumeral joint; - ununited humeral head fractures of long duration; - irreducible 3-and 4-part proximal humeral fractures; - avascular necrosis of the humeral head, or other difficult clinical management problems where arthrodesis or resectional arthroplasty is not acceptable.

    FDA Recall
    Terminated ·Zimmer Inc.·Product code KWT·September 10, 2010

    SMR Shoulder/Spalla Trial Humeral Head diameter .42 mm, REF 9013.22.425; SMR Shoulder/Spalla Trial Humeral Head diameter .44 mm, REF 9013.22.445; SMR Shoulder/Spalla Trial Humeral Head diameter .46 mm, REF 9013.22.465; for use in shoulder implant surgery.

    FDA Recall
    Terminated ·Limacorporate S.p.A Via Nazionale 52 San Daniele Del Friuli Italy·Product code KWT·August 14, 2015

    BF Humeral Stem, Various Sizes, Item Nos. 00430000606 00430000613 00430000706 00430000713 00430000813 00430000817 00430000820 00430000913 00430001013 00430001017 00430001020 00430001113 00430001213 00430001217 00430001220 00430001313 00430001413 00430001417 00430001420 00430001513 00430001613 00430001713 00430001813 47430103100

    FDA Recall
    Terminated ·Zimmer Biomet, Inc.·Product code KWT·October 10, 2019

    Zimmer Inverse/Reverse Screw system,

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code KWT·September 4, 2012