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 |
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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.
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510(K) Database | 510(K)s with Product Code = JWH
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