Tornier, Inc recalls Stryker Tornier Perform Humeral System, Reversed Insert, 45%, REF DWP2393, for shoulder arthroplasty

Recall date

August 29, 2024

Source

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

Recall number

Z-3309-2024

FDA classification

Class II

Brand / firm

Tornier, Inc

Sold / distributed

US Nationwide distribution.

Why it was recalled

Devices from one lot of Perform" Reversed Inserts may contain a locking ring that was assembled upside down which would prevent the humeral insert from securely seating in the stem or spacer.

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

What was recalled

Stryker Tornier Perform Humeral System, Reversed Insert, 45%, REF DWP2393, for shoulder arthroplasty