Radian Head and Uni-Elbow (2017-10-17)

Starting date:

October 17, 2017

Posting date:

December 8, 2017

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-65332

• Reason
• Affected products

Affected products

A. RECON - RADIAL IMPLANT - HEAD
B. RECON - RADIAL IMPLANT - STANDARD
C. RHEAD, RADIAL IMPLANT, HEAD
D. RHEAD, RADIAL IMPLANT, STANDARD STEM
E. RADIAL BROACH ASSY
F. RESECTION GUIDE RHEAD
G. STANDARD HEAD TRIAL
H. STANDARD STEM TRIAL
I. RHEAD RECON ASSEMBLY TOOL
J. RHEAD EXTENDED STEM AWL

Reason

The result of an audit review [conducted during the month of August, 2017] of the currently available data of the Stryker rHead Radial Head and UNI-Elbow system was found to be inconclusive to continue supporting the performance of the device. Consequently, Stryker has decided to remove the product from the global markets.

Affected products