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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 Recall
Duracon Total Knee Distal Femoral Locking Screw
see related information
Date Posted October 06, 2010
Recall Status1 Terminated on October 07, 2010
Recall Number Z-0014-2011
Recall Event ID 50100
Premarket Notification
510(K) Number
K920034 
Product Classification Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - 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, New Jersey 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
PRODUCTION CONTROLS: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JWH and Original Applicant = PFIZER HOSPITAL PRODUCTS GROUP, INC.
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