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/ Manufacturer |
Stryker Howmedica Osteonics Corp. 325 Corporate Dr Mahwah NJ 07430-2002
|
For Additional Information Contact |
Rose Mincieli 201-831-5832
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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 |
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
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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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