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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-0472-2007
Recall Event ID 36973
Product Classification Hip Stem - Product Code KWL
Product Howmedica Hip Fracture Stem System, Product Number: 6942-0-10, No. 1 Femoral Component, Fenestrated
Sterile

Made in Ireland
Code Information Hip Fracture Stem # 1; Catalog Number 6942-0-010; Lot codes: 6499601, 6660201, 6660202, 6660203, 6660204, 6660205, 7237401, 7237402, 7237403, 7237404, 7237405, 7934101, 7934102, 7934103, 7934104, 7934105, 8345801, 8345802, 8345803, 8345804, 9714001, 9911901, 9911902, 10420701, 10420702, 10756001, 11319201, 11369101, 11369102, 11369103, 11605201, 11605202, 13093201, 13093301, 13093302,13093401, 13093501, 13562501, 13562502, 13782001, 15550502, 16060001, 16060002, 16840301, 17289301, 17289302, 18448101, 18448102, 18448103, 18593901, 14413201R, P4FEA.
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 193 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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