FDA recall Z-1173-2018

Product

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

Reason for recall

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.

Distribution

Distribution US Nationwide

Key facts

Status

Terminated

Initiation date

2018-02-28

Report date

2018-04-04

Termination date

2020-08-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Warsaw, IN, United States

Primary source

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