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 Onmifit HFX Hip Stem

  • 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 Onmifit HFX Hip Stemsee related information
Date Initiated by FirmNovember 13, 2008
Date PostedJanuary 26, 2009
Recall Status1 Terminated 3 on January 20, 2010
Recall NumberZ-0896-2009
Recall Event ID 50485
510(K)NumberK031744 
Product Classification prosthesis, hip, - Product Code JDI
ProductOmnifit HFX Hip Stem 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 6070-0730A OMNIFIT HFX HIP STEM SIZE #07 132 P7MMME, 6070-0730A OMNIFIT HFX HIP STEM SIZE #07 132 RHWMME, 6070-0730A OMNIFIT HFX HIP STEM SIZE #07 132 VJMMME, 6070-0830A OMNIFIT HFX HIP STEM SIZE #08 132 0J0MNE, 6070-0830A OMNIFIT HFX HIP STEM SIZE #08 132 D9VMME, 6070-0830A OMNIFIT HFX HIP STEM SIZE #08 132 T9RMME, 6070-0830A OMNIFIT HFX HIP STEM SIZE #08 132 VK0MME, 6070-0935A OMNIFIT HFX HIP STEM SIZE #09 132 0HDMNE, 6070-0935A OMNIFIT HFX HIP STEM SIZE #09 132 0HEMNE, 6070-0935A OMNIFIT HFX HIP STEM SIZE #09 132 P7XMME, 6070-0935A OMNIFIT HFX HIP STEM SIZE #09 132 RE8MME, 6070-0935A OMNIFIT HFX HIP STEM SIZE #09 132 REDMME, 6070-0935A OMNIFIT HFX HIP STEM SIZE #09 132 VK2MME, 6070-0935A OMNIFIT HFX HIP STEM SIZE #09 132 VK3MME and 6070-1140A OMNIFIT HFX HIP STEM SIZE #11 132 0HKMNE 
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 = JDI
-
-