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Smith & Nephew Orthopaedics AG recalls POLARSTEM COLLAR Reamer Guide, Catalog Number: 75102205, UPC Codes: 00885556535493 - Product Usage: Once the appropriate
Recalled August 26, 2020 · FDA recall Z-2827-2020 · Smith & Nephew Orthopaedics AG
Hazard
Multiple lots being recalled due to a product design issue · FDA Class II
Units
528 unit
Sold at
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.
Description
Multiple lots being recalled due to a product design issue
Product
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.
Manufacturer(s)
Smith & Nephew Orthopaedics AG
Made in
Switzerland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →