FDA-Device2021-02-17Class II
Universal Femoral Sleeves - Product Usage: used primarily in revision surgeries with the S-ROM Noiles, LPS, SIGMA, and LCS Knee products.
DePuy Orthopaedics, Inc.
Hazard
The taper dimensions may be out of specification due to a production issue during the manufacturing of these lots.
Sold states
Worldwide distribution - US Nationwide distribution in the states of AK, CA, FL, IN, MI, MN, MS, NC, NY, OH, PA, TX, VA and the countries of Canada, China, Germany, Puerto Rico, Switzerland.
Affected count
60 sleeves
Manufactured in
700 Orthopaedic Dr, N/A, Warsaw, IN, United States
Products
Universal Femoral Sleeves - Product Usage: used primarily in revision surgeries with the S-ROM Noiles, LPS, SIGMA, and LCS Knee products.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1103-2021Don't want to check this manually?
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