FDA-Device2013-01-16Class II
Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #2.5 and Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #3.5, Howmedica Osteonics Corp. The intended use is for reconstruction of the head and neck of the femoral joint.
Stryker Howmedica Osteonics Corp.
Hazard
Stryker has received a report that single size 3.5 stem was packaged as size 2.5 stem resulting in a possible product mix.
Sold states
Nationwide distribution, including the states of NY, NJ, CA and FL.
Affected count
6021-2530- four units; 6021-3535-
Manufactured in
325 Corporate Drive, Mahwah, NJ, United States
Products
Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #2.5 and Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #3.5, Howmedica Osteonics Corp. The intended use is for reconstruction of the head and neck of the femoral joint.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0656-2013Don't want to check this manually?
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