Comprehensive Segmental Revision System (SRS)/Discovery Distal Body with Screw 50mm-70mm (2018-03-13)

Starting date:

March 13, 2018

Posting date:

March 23, 2018

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-66274

• Reason
• Affected products

Affected products

Comprehensive Segmental Revision System (SRS)/Discovery Distal Body with Screw 50mm-70mm

Reason

Zimmer Biomet is conducting a recall of specific lots of the comprehensive Segmental Revision System (SRS)/discovery distal body with screw. Zimmer Biomet has received reports that 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 occurred between the screw holes in the distal humeral body and the discovery elbow condyle implant during vendor machine operation. The mismatch does not always prevent engagement of the screw and the condition would be noticed during assembly.

Affected products