FDAFDA · Food and drugs·Recall number Z-0467-2014
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.
Published December 18, 2013 · Recall initiated: October 25, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Stryker Howmedica Osteonics Corp.
- Distributor
- Nationwide Distribution including states: AL, GA, IL, and WA.
- Lot
- 510K K120578 Accolade II I27 Neck Angle Hip Stem, Size # 3 Catalog No.# 6721-0330 Lot Code #44416307 Accolade II 127 Neck Angle Hip Stem, Size #5 Catalog No. # 6721-0535 Lot Code 44564405
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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