FDA-Device2015-07-08Class II
Natural Knee II Revision Femoral Stem, 125mm, item 6215-12-185. packaged in configuration 803/791. Knee Prosthesis component.
Zimmer, Inc.
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.
Sold states
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.
Affected count
352
Manufactured in
1800 W Center St, Warsaw, IN, United States
Products
Natural Knee II Revision Femoral Stem, 125mm, item 6215-12-185. packaged in configuration 803/791. Knee Prosthesis component.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1948-2015Don't want to check this manually?
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