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U.S. Department of Health and Human Services

Class 2 Device Recall Howmedica HIp Stem

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  Class 2 Device Recall Howmedica HIp Stem see related information
Date Initiated by Firm November 28, 2006
Date Posted January 13, 2007
Recall Status1 Terminated 3 on May 08, 2007
Recall Number Z-0475-2007
Recall Event ID 36973
Product Classification Hip Stem - Product Code KWL
Product Howmedica 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.
Recalling Firm/
Manufacturer
Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2002
For Additional Information Contact Larry 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
Action Recall notification letters and product accountability forms were sent on 11/29 via Fed Ex with return receipt.
Quantity in Commerce 126 units
Distribution Nationwide
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.
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