Biomet, Inc. recalls Zimmer Biomet Comprehensive Segmental Revision System (SRS). Orthopedic implants for Proximal Humeral Reconstruction, D…

Recall date

February 28, 2018

Source

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

Recall number

Z-1173-2018

FDA classification

Class II

Brand / firm

Biomet, Inc.

Sold / distributed

Distribution US Nationwide

Why it was recalled

During assembly, an SRS Humeral Distal Body implant failed to engage correctly at the point of reduction with a Discovery Elbow System Humeral Condyle. A mismatch between the screw holes in the Humeral Body & Elbow Condyle affects assembly during surgery. If the product has already been implanted, no action is required. The mismatch is estimated to prevent screw engagement in less than 1% of cases.

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

What was recalled

Zimmer Biomet Comprehensive Segmental Revision System (SRS). Orthopedic implants for Proximal Humeral Reconstruction, Distal Humeral Reconstruction, and Total Humeral Reconstruction