Smith & Nephew Orthopaedics AG recalls POLARSTEM COLLAR Reamer Guide, Catalog Number: 75102205, UPC Codes: 00885556535493 - Product Usage: Once the appropriat…

Recall date

July 22, 2020

Source

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

Recall number

Z-2827-2020

FDA classification

Class II

Brand / firm

Smith & Nephew Orthopaedics AG

Sold / distributed

Worldwide distribution - US Nationwide distribution including in the state of TN and the countries of AU, BE, CA, CH, ES, FR, GB, JP, NL, NO, PL, SG, ZA.

Why it was recalled

Multiple lots being recalled due to a product design issue

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

What was recalled

POLARSTEM COLLAR Reamer Guide, Catalog Number: 75102205, UPC Codes: 00885556535493 - Product Usage: Once the appropriate trial rasp size is in place, the adapter is removed and the calcar reamer guide (75102205) is positioned on the rasp. The calcar reamer (75102207 or 75102208) is placed over the reamer guide and the femoral neck is machined until the reamer reach the physical stop-fully seated on the inner reamer guide.