FDA Enforcement
Class II
Terminated
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
Recall: Z-1020-2017
·
Reported January 18, 2017
Enforcement
- Recall Number
- Z-1020-2017
- Event ID
- 75889
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Stryker Howmedica Osteonics Corp.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 18, 2017
- Initiation Date
- December 2, 2016
- Classification Date
- January 12, 2017
- Termination Date
- August 1, 2018
- Address
- 325 Corporate Dr, Mahwah, NJ, 07430-2006, United States
Description
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
Reason
Reunion TSA Peg Alignment Sound broke during surgery.
Code Info
Catalog #5901-1038
Distribution
Nationwide Distribution
Quantity
131 units