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Zimmer, Inc. recalls Natural Knee II Revision Femoral Stem, 125mm, item 6215-12-185. packaged in configuration 803/791. Knee Prosthesis com
Recalled July 8, 2015 · FDA recall Z-1948-2015 · Zimmer
Hazard
Failed to meet established requirements for sterile barrier integrity due to a breach of the inner cavity. If the outer tray is compromised in addition to the inner tray a periprosthetic infection may occur. The risk associated with a periprosthetic infection is a revision or potential multi-stage revision to treat the infection. · FDA Class II
Units
352
Sold at
US Nationwide Distribution, including DC and the states of AL, AZ, CA, CO, FL, GA, IL, IN, KS, LA, MD, MI, MN, MO, MT, NC, ND, NJ, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, WI, and WY.
Description
Failed to meet established requirements for sterile barrier integrity due to a breach of the inner cavity. If the outer tray is compromised in addition to the inner tray a periprosthetic infection may occur. The risk associated with a periprosthetic infection is a revision or potential multi-stage revision to treat the infection.
Product
Natural Knee II Revision Femoral Stem, 125mm, item 6215-12-185. packaged in configuration 803/791. Knee Prosthesis component.
Manufacturer(s)
Zimmer, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →