FDA-Device2018-04-04Class II

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

Biomet, Inc.
Hazard

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.

Sold states
Distribution US Nationwide
Affected count
634
Manufactured in
56 E Bell Dr, Warsaw, IN, United States
Products
Zimmer Biomet Comprehensive Segmental Revision System (SRS). Orthopedic implants for Proximal Humeral Reconstruction, Distal Humeral Reconstruction, and Total Humeral Reconstruction

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1173-2018

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