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 Rejuvenate Broach

  • 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 Rejuvenate Broach see related information
Date Initiated by Firm January 25, 2008
Date Posted September 19, 2008
Recall Status1 Terminated 3 on September 22, 2008
Recall Number Z-2349-2008
Recall Event ID 49087
Product Classification Broach - Product Code HTQ
Product Rejuvenate Broach
Catalog No: 1601-1005, 1601-1006, 1601-1007, 1601-1008, 1601-1009, 1601-1010
Stryker Orthopaedics,
Mahwah, NJ. 07430

Contours the proximal femur to the geometry of the stem to provide a complimentary fit of the stem to the bone.The broaches are designed with a series of teeth that are intended to seat against highly densified cancellous bone for the interference press-fit in the uncemented application.
Code Information All Lot Codes
Recalling Firm/
Manufacturer		 Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2002
For Additional Information Contact Karen Aremia
201-831-5000
Manufacturer Reason
for Recall		 Rejuvenate Broach system was designed in a manner that may result in the potential for a medical calcar fracture.
FDA Determined
Cause 2		 Device Design
Action Stryker notified all branches and agencies to return the product on January 25, 2008. A formal recall letter was not written as all product was in their control.
Quantity in Commerce 78 devices
Distribution Nationwide Distribution.
Total Product Life Cycle TPLC 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.
-
-