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Zimmer Gmbh recalls Metasul Femoral Head - indicated for total hip arthroplasty for treatment of patient conditions of non-inflammatory deg
Recalled March 4, 2015 · FDA recall Z-1136-2015 · Zimmer
Hazard
Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in surgery may result. If undetected breach in both the inner and outer trays were to occur, and there is contamination present, a periprosthetic infection is possible, which could lead to revision. · FDA Class II
Units
16
Sold at
Domestic: AK, AL, AR, AZ, CA, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MS, MA, MD, ME, MI, MN, MO, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY International: Canada, Japan
Description
Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in surgery may result. If undetected breach in both the inner and outer trays were to occur, and there is contamination present, a periprosthetic infection is possible, which could lead to revision.
Product
Metasul Femoral Head - indicated for total hip arthroplasty for treatment of patient conditions of non-inflammatory degenerative joint disease.
Manufacturer(s)
Zimmer Gmbh
Made in
Switzerland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →