FDA-Device2017-01-18Class II
Reunion TSA Peg Alignment Sound Catalog #5901-1038 The Peg Alignment Sound (PIN 5901-1038, Revision A) is an instrument used in the ReUnion TSA shoulder system for confirming seating height and peg alignment of the TSA Self-Pressurizing Polyethylene Glenoid implant prior to final implantation into the glenoid vault. Its purpose is to provide assurance that the drilled holes for seating of the Glenoid implant have been properly prepared using the provided instrumentation
Stryker Howmedica Osteonics Corp.
Hazard
Reunion TSA Peg Alignment Sound broke during surgery.
Sold states
Nationwide Distribution
Affected count
131 units
Manufactured in
325 Corporate Dr, Mahwah, NJ, United States
Products
Reunion TSA Peg Alignment Sound Catalog #5901-1038 The Peg Alignment Sound (PIN 5901-1038, Revision A) is an instrument used in the ReUnion TSA shoulder system for confirming seating height and peg alignment of the TSA Self-Pressurizing Polyethylene Glenoid implant prior to final implantation into the glenoid vault. Its purpose is to provide assurance that the drilled holes for seating of the Glenoid implant have been properly prepared using the provided instrumentation
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1020-2017Don't want to check this manually?
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