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DePuy Orthopaedics, Inc. recalls Universal Femoral Sleeves - Product Usage: used primarily in revision surgeries with the S-ROM Noiles, LPS, SIGMA, and L
Recalled February 17, 2021 · FDA recall Z-1103-2021 · DePuy Orthopaedics
Hazard
The taper dimensions may be out of specification due to a production issue during the manufacturing of these lots. · FDA Class II
Units
60 sleeves
Sold at
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.
Description
The taper dimensions may be out of specification due to a production issue during the manufacturing of these lots.
Product
Universal Femoral Sleeves - Product Usage: used primarily in revision surgeries with the S-ROM Noiles, LPS, SIGMA, and LCS Knee products.
Manufacturer(s)
DePuy Orthopaedics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →