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 Howmedica 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 Howmedica HIp Stemsee related information
Date Initiated by FirmNovember 28, 2006
Date PostedJanuary 13, 2007
Recall Status1 Terminated 3 on May 08, 2007
Recall NumberZ-0475-2007
Recall Event ID 36973
Product Classification Hip Stem - Product Code KWL
ProductHowmedica Hip Fracture Stem System No. 3.5 Femoral Component Uses No. 3 Fenestrated Plus Sterile REF Catalogue #6942-0-035 Made in Ireland
Code Information Hip Fracture Stem # 3.5; Catalog number 6942-0-035; Lot codes: 7566701, 7819401, 7819402, 7819403, 7819405, 7869001, 7869002, 7869003, 7869004, 7869005, 7935701, 7935702, 7935704, 7999901, 7999902, 8152301, 8152302, 8152303, 8242501, 8850401, 8850402, 8850403, 8850404, 9503301, 9844801, 9844802, 9948201, 9948203, 10546201, 10546202, 10673501, 11090201, 11319301, 11319302, 11319303, 11369601, 11605702, 16033902, 16033903, 16165902, 16166001, 16840401, 16840402, 17289401, 17289402, 18448001, 18448002, 19131601, 10131602, 19490903, 19490904, 19834301.
FEI Number 3003070421
Recalling Firm/
Manufacturer		 Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2002
For Additional Information ContactLarry Ross
201-831-5972
Manufacturer Reason
for Recall		Lack of assurance of Sterility (package integrity): Anomalies in seal width and strength that may affect the integrity of the sterile barrier.
FDA Determined
Cause 2		Other
ActionRecall notification letters and product accountability forms were sent on 11/29 via Fed Ex with return receipt.
Quantity in Commerce126 units
DistributionNationwide
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.
-
-