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U.S. Department of Health and Human Services

Class 2 Device Recall Hipstar TMZF

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  Class 2 Device Recall Hipstar TMZF see related information
Date Initiated by Firm September 28, 2007
Date Posted December 14, 2007
Recall Status1 Terminated 3 on September 05, 2008
Recall Number Z-0475-2008
Recall Event ID 45982
Product Classification Hip Stem Protocol - Product Code LPH
Product Hipstar TMZF Cementless Hip Stem Protocol, Product Number: LSP60.
Code Information Literature # LPS60 (Lot code n/a)
Recalling Firm/
Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2002
For Additional Information Contact Rose Mincieli
Manufacturer Reason
for Recall
Mis-labeling: An error on page 4 of the Hipstar protocol was found. In the table for compatible Heads, the 40 mm diameter heads with a Neck Length of +12 should have been omitted.
FDA Determined
Cause 2
Action Urgent Product Correction Letters, dated 10/17/2007 were sent on 10/17/07by Federal Express to all Stryker Branches/Agencies who had received the protocol. The branches were instructed to quarantine and destroy the protocols.
Quantity in Commerce 192 protocols
Distribution Nationwide:The protocol was distributed to 9 Stryker branches/agencies in NJ, MD, IN, MI, MN, IL and TX.
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.