Metasul Femoral Head - indicated for total hip arthroplasty for treatment of patient conditions ...
FDA Recall #Z-1136-2015 — Class II — December 17, 2014
Product Description
Metasul Femoral Head - indicated for total hip arthroplasty for treatment of patient conditions of non-inflammatory degenerative joint disease.
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
16
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: 734028800 Lot #'s: 61487614
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated