Stryker Howmedica Osteonics Corp. recalls Triathlon Distal Capture Assembly Catalog No: 6541-1-723 The Triathlon Distal Capture Assembly is used when a surgeon e…

Recall date

February 12, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1283-2015

FDA classification

Class II

Brand / firm

Stryker Howmedica Osteonics Corp.

Sold / distributed

Worldwide Distribution - USA (nationwide) Puerto Rico, and Internationally to Canada, Hong Kong, Netherlands, Sweden, Switzerland, Spain, France, Italy, UK, India, Australia, Korea, Panama, Polan, Ireland, Kuala Lumpar, New Zealand and South Africa.

Why it was recalled

Potential for weld disassociation of the cross pin, which could lead to loose or disassociated trigger mechanism on the Distal Capture Assembly.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Triathlon Distal Capture Assembly Catalog No: 6541-1-723 The Triathlon Distal Capture Assembly is used when a surgeon elects to use a capture for the distal femoral resection or proximal tibial resection in a Triathlon primary total knee arthroplasty (TKA).