Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Accolade C CS

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Accolade C CSsee related information
Date Initiated by FirmNovember 13, 2008
Date PostedJanuary 26, 2009
Recall Status1 Terminated 3 on January 20, 2010
Recall NumberZ-0895-2009
Recall Event ID 50485
510(K)NumberK022555 
Product Classification prosthesis, hip, - Product Code LZO
ProductAccolade C CS These devices are modular components of a total hip system. These femoral stems are intended for use with femoral heads and acetabular components in primary or revision total hip arthroplasty.
Code Information 6057-0335D ACCOLADE C CS 127 NK JYLMME,  6057-0537D ACCOLADE C CS 127 NK JYNMME,  6057-0740D ACCOLADE C CS 127 NK E5EMME and 6058-0335D ACCOLADE C CS 132 NK JYVMME  
Recalling Firm/
Manufacturer		 Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430
For Additional Information ContactKaren Ariemma, RAC
201-831-5000
Manufacturer Reason
for Recall		Stryker Orthopaedics became aware of a visual defect in certain blister packages of certain devices.
FDA Determined
Cause 2		Packaging
ActionRecall notification letters were sent via Federal Express on November 21, 2008 to Stryker Branches/Agencies, Hospital Risk Management, Chief of Orthopaedics and Surgeon. The letters explained the problem and indicated that there are no risk factors. Contact Stryker Orthopaedics for additional information at 1-201-831-5718.
Quantity in Commerce322 total units - all types
DistributionNationwide. OUS: Australia, Canada, Japan, Argentina, Brazil, Germany, Spain, Columbia, Guatemala and Sweden.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = LZO
-
-