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U.S. Department of Health and Human Services

Class 2 Device Recall Citation TMZF HA Hip Stem Right

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  Class 2 Device Recall Citation TMZF HA Hip Stem Right see related information
Date Initiated by Firm November 12, 2002
Date Posted December 19, 2002
Recall Status1 Terminated 3 on April 04, 2003
Recall Number Z-0349-03
Recall Event ID 25085
510(K)Number K993768  
Product Classification Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate - Product Code MEH
Product Citation TMZF HA Hip Stem Right (Femoral Hip Prosthesis)
Catalog No. 6265-5116
Code Information Lot Codes: 1187701, 1233101, 1187701
Recalling Firm/
Manufacturer		 Howmedica Osteonics Corp
359 Veterans Blvd
Rutherford NJ 07070
For Additional Information Contact Thomas Grzeskowiak
201-831-5495
Manufacturer Reason
for Recall		 Hip Stem Fractures in the neck area.
FDA Determined
Cause 2		 Other
Action Letters to Surgeons was sent certified mail on Nov. 4, 2002. Letters to Howmedica agents send on Nov. 12, 2002.
Quantity in Commerce 16
Distribution Product was distributed to hospitals and Howmedica Branch reps throughout the US.
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.
510(K) Database 510(K)s with Product Code = MEH and Original Applicant = HOWMEDICA OSTEONICS CORP.
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