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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Sklar Instruments IV Cath Dressing Tray Cs/25 Re-Order Number: 96-1708
FDA Recall
Terminated
·Trinity Sterile, Inc.·Product code OXQ·June 29, 2022
Sklar Instruments IV Cath Dressing Tray Cs/25 Re-Order Number: 96-1708
FDA Enforcement
Class II
·Terminated·Trinity Sterile, Inc.·August 24, 2022
Osteonics Shoulder Glenoid Spanner Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430. The Solar Upper Extremity System Hemi and Total Shoulder Arthroplasty system is designed to address the most common arthritic disorders affecting the shoulder. The spherical reamer is used to prepare the glenoid fossa and provide a uniform surface for instrumentation and implant placement. The glenoid fossa is then sized using surface templates to confirm the appropriate coverage, size and curvature has been determined. To achieve this in surgery, the spherical reamer (5900-2050/-2051/-2052/-2053) must be attached to the Angled Glenoid Driver (5900-2040) by threading the reamer's male threads into the driver's female threads. The spherical reamers come in sizes 5, 7, 9 & 11, each with a captive drill head screw (5900-2054/-2055). The spanner features two kidney shaped male lobes that mate with two similar kidney shaped female slots in the screw's head and is used to tighten and loosen the spherical reamers with the angled driver. These instruments are part of the Solar Total Shoulder Instrument set and can be found in Surgical Protocol LSPUE-4 dated 10/04. Each set contains one spanner that universally fits all size reamers.
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code LXH·November 17, 2011