Stryker Howmedica Osteonics Corp. recalls Reunion TSA Peg Alignment Sound Catalog #5901-1038 The Peg Alignment Sound (PIN 5901-1038, Revision A) is an instrument…

Recall date

December 2, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1020-2017

FDA classification

Class II

Brand / firm

Stryker Howmedica Osteonics Corp.

Sold / distributed

Nationwide Distribution

Why it was recalled

Reunion TSA Peg Alignment Sound broke during surgery.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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