FDA-Device2013-12-18Class II
1) Accolade II 127 Neck Angle Hip Stem, Size # 3 2) Accolade II 127 Neck Angle Hip Stem, Size #5 Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 USA Telephone # +1 201-831-5000 Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 MEYZIEU Cedex France Intended for cementless application in total or hemiarthroplasty procedures.
Stryker Howmedica Osteonics Corp.
Hazard
Stryker received a report from the field indicating that an Accolade II Hip Stem Size #3 was identified in packaging with an Accolade II Hip Stem Size #5.
Sold states
Nationwide Distribution including states: AL, GA, IL, and WA.
Affected count
20 units
Manufactured in
325 Corporate Dr, Mahwah, NJ, United States
Products
1) Accolade II 127 Neck Angle Hip Stem, Size # 3 2) Accolade II 127 Neck Angle Hip Stem, Size #5 Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 USA Telephone # +1 201-831-5000 Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 MEYZIEU Cedex France Intended for cementless application in total or hemiarthroplasty procedures.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0467-2014Don't want to check this manually?
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