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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/
Manufacturer		 Stryker Howmedica Osteonics
300 Commerce Court
Mahwah NJ 07430
For Additional Information Contact Dominick Cristofolo
201-837-5247
Manufacturer Reason
for Recall		 The device does not have an oblong hole for dynamic locking as required.
FDA Determined
Cause 2		 Other
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.
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