Metasul Femoral Head - A modular head component is used in conjunction with a femoral stem compon...
FDA Recall #Z-1133-2015 — Class II — December 17, 2014
Product Description
Metasul 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.
Reason for Recall
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.
Recalling Firm
Zimmer Gmbh — Winterthur, N/A
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
30
Distribution
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
Code Information
Item numbers: 19.32.05; 19.32.06; 19.32.08; Lot #'s: 2560585, 2553420, 2556039, 2560586, 2563398
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated