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U.S. Department of Health and Human Services

Class 3 Device Recall Howmedica

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  Class 3 Device Recall Howmedica see related information
Date Initiated by Firm August 04, 2003
Date Posted October 15, 2003
Recall Status1 Terminated 3 on September 30, 2003
Recall Number Z-1295-03
Recall Event ID 26996
510(K)Number K003018  
Product Classification Rod, Fixation, Intramedullary And Accessories - Product Code HSB
Product T2 Tibia Nail, Standard 9 x 300 mm, T2 Tibia System, Catalog No. 1822-0930S.
Code Information Lot K884459
Recalling Firm/
Stryker Howmedica Osteonics
300 Commerce Court
Mahwah NJ 07430
For Additional Information Contact Dominick Cristofolo
Manufacturer Reason
for Recall
The device does not have an oblong hole for dynamic locking as required.
FDA Determined
Cause 2
Action Product recall letters and Product accountability forms were sent via FedEx on 8/4/2003 with return receipt.
Quantity in Commerce 6
Distribution The 6 units were distributed to Howmedica Branch and sales agents located in PA, VA, GA, KS, and CA.
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 = HSB and Original Applicant = HOWMEDICA OSTEONICS CORP.