Date Initiated by Firm | August 04, 2008 |
Date Posted | September 29, 2008 |
Recall Status1 |
Terminated 3 on August 03, 2009 |
Recall Number | Z-2466-2008 |
Recall Event ID |
49116 |
510(K)Number | K923277 K941306 K970031 |
Product Classification |
Prosthesis, knee - Product Code JWH
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Product | FOUNDATION KNEE SYSTEM Tibial Fixed Impactor, Revision A and B; Catalog #801-01-449; distributed by Encore Medical, L.P., Austin, TX 78758. The Tibial Fixed Impactor, a part of the FOUNDATION KNEE SYSTEM, is a manual orthopedic surgical instrument intended to lock onto the baseplate to impact the implant. |
Code Information |
All Revision A and Revision B Impactors. |
Recalling Firm/ Manufacturer |
Encore Medical, Lp 9800 Metric Blvd Austin TX 78758
|
For Additional Information Contact | 512-832-9500 |
Manufacturer Reason for Recall | Complaints received regarding the fracture of the Nitronic 60 screw on the Tibial Fixed Impactor during surgery. |
FDA Determined Cause 2 | Device Design |
Action | Recall notification sent via letter starting on 08/04/07. Consignees asked to quarantine and return affected devices. Contact Encore Medical, Lp at 1-512-834-6330 for assistance. |
Quantity in Commerce | 68 units. |
Distribution | FL and TX and OUS: Japan. |
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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