Zimmer Gmbh recalls CoCr Femoral Head - A modular head component is used in conjunction with a femoral stem component for replacement of th…

Recall date

December 17, 2014

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1132-2015

FDA classification

Class II

Brand / firm

Zimmer Gmbh

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

CoCr Femoral Head - A modular head component is used in conjunction with a femoral stem component for replacement of the proximal femur in total hip arthroplasty.