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U.S. Department of Health and Human Services

Class 2 Device Recall Gamma 3 Long Nail Kit R2.0

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  Class 2 Device Recall Gamma 3 Long Nail Kit R2.0 see related information
Date Initiated by Firm July 23, 2010
Date Posted September 02, 2010
Recall Status1 Terminated 3 on August 06, 2012
Recall Number Z-2340-2010
Recall Event ID 56364
510(K)Number K034002  
Product Classification Intramedullary Fixation Rod and Accessories - Product Code HSB
Product Long Nail Kit R2.0, Ti RIGHT 011x360 mm x 125 degrees;
Sterile, TI Alloy, Implant; Catalog number 3225-0360S.
Stryker Trauma GmbH, 24232 Schenjrchen, Germany;
distributed in USA by Howmedica Osteonics Corp, 325 Corporate Drive, Mahwah, NJ 07430.

Intended for temporary fixation, correction, or stabilization of the right femur.
Code Information Lot code K248963; Expiration: 8/14/2014.
Recalling Firm/
Manufacturer		 Stryker Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah NJ 07430
For Additional Information Contact Colleen O'Meara
201-831-5970
Manufacturer Reason
for Recall		 The nail has no thread for the set screw hindering insertion.
FDA Determined
Cause 2		 Process control
Action Urgent Product Recall letters were sent on July 23, 2010 by Federal Express to Stryker branches. A corrected letter was sent on July 26, 2010 to correct an error in the size of the screw. Additionally, letters were sent on July 26, 2010 to Hospital Risk Managers, Chief of Orthopaedics and Surgeons. The letter identified the affected product, explained the issue, discussed the potential hazard, and the risk mitigation. Customers are to examine their inventory, retrieve all affected product and return it; then reconcile all products on the Product Recall Acknowledgement Form and fax it back. Questions should be directed towards Richard Wolyn at 201-972-2100.
Quantity in Commerce 12 units
Distribution Nationwide Distribution -- NJ, NY, DE, IN, WI, IL, PA and NM.
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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