PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: April 4, 2018 Initiated: February 28, 2018 #Z-1173-2018

Product Description

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.

Details

Recalling Firm
Biomet, Inc.
Units Affected
634
Distribution
Distribution US Nationwide
Location
Warsaw, IN

Frequently Asked Questions

What product was recalled?
Zimmer Biomet Comprehensive Segmental Revision System (SRS). Orthopedic implants for Proximal Humeral Reconstruction, Distal Humeral Reconstruction, and Total Humeral Reconstruction. Recalled by Biomet, Inc.. Units affected: 634.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on April 4, 2018. Severity: Moderate. Recall number: Z-1173-2018.