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U.S. Department of Health and Human Services

Class 2 Device Recall Duracon Total Knee Distal Femoral Locking Screw

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  Class 2 Device Recall Duracon Total Knee Distal Femoral Locking Screw see related information
Date Initiated by Firm October 05, 2006
Date Posted October 06, 2010
Recall Status1 Terminated 3 on October 07, 2010
Recall Number Z-0014-2011
Recall Event ID 50100
510(K)Number K920034  
Product Classification Knee Patellofemorotibial Polymer/Metal/Polymer Semi-Constrained Cemented Prosthesis - Product Code JWH
Product Duracon Total Knee Distal Femoral Locking Screw for 5 mm Spacer; Product No. 6632-5-600.

Made in Ireland;
Howmedica Osteonics;
325 Corporate Drive,
Mahwah, NJ 07430

Intended for primary or secondary reconstruction of the distal femur.
Code Information Lot Code: LADLF
Recalling Firm/
Manufacturer		 Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430
For Additional Information Contact Rita Intorella
201-831-5000
Manufacturer Reason
for Recall		 Stryker Orthopaedics became aware that a box labeled as Duracon Total Knee Distal Femoral Locking Screws for 5 mm spacer, may actually contain a 10 mm screw.
FDA Determined
Cause 2		 Labeling mix-ups
Action Important Market Withdrawal Letters were sent via Federal Express October 5, 2006. The letters identified the affected product and the reason for recall. Customers were asked to examine their inventory to identify the product; and retrieve all affected product lots and return it their branch or agency warehouse for reconciliation. All product should be reconciled on the Product Accountability Form and the form should be faxed back. Customers are to contact a Customer Service Rep to re-order the product that is being returned. Questions can be directed to Rita Intorrella on 201-831-5825.
Quantity in Commerce 7 units
Distribution Nationwide Distribution -- Including Ohio.
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 = JWH and Original Applicant = PFIZER HOSPITAL PRODUCTS GROUP, INC.
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