Class 2 Device Recall Hipstar TMZF

• Date Initiated by Firm: September 28, 2007
• Date Posted: December 14, 2007
• Recall Status: Terminated 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)
• FEI Number: 3003070421
• Recalling Firm/ Manufacturer: Stryker Howmedica Osteonics Corp.; 325 Corporate Dr; Mahwah NJ 07430-2002
• For Additional Information Contact: Rose Mincieli; 201-831-5832
• 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: Other
• 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.