Device product
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
Z-1020-2017
Product summary
- Event
- Event 75889
- Status
- Terminated
- Classification
- Class II
- Quantity
- 131 units
- Official record key
device-enforcement:Z-1020-2017
Official wording
Reason: Reunion TSA Peg Alignment Sound broke during surgery.
Code information: Catalog #5901-1038
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Unknown
Reunion TSA Peg Alignment Sound broke during surgery.