Z-1020-2017 Class II Terminated

Recalled by Stryker Howmedica Osteonics Corp. — Mahwah, NJ

Recall Details

Product Type
Devices
Report Date
January 18, 2017
Initiation Date
December 2, 2016
Termination Date
August 1, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
131 units

Product 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 for Recall

Reunion TSA Peg Alignment Sound broke during surgery.

Distribution Pattern

Nationwide Distribution

Code Information

Catalog #5901-1038