Date Initiated by Firm | May 29, 2009 |
Date Posted | September 09, 2009 |
Recall Status1 |
Terminated 3 on May 11, 2010 |
Recall Number | Z-1993-2009 |
Recall Event ID |
52423 |
510(K)Number | K994370 |
Product Classification |
Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
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Product | Tibial Tray, component of Ortho Development Balanced Knee System, Nonporous, Sterile R, Size 3, REF 162-1300, Ortho Development, Draper, Utah 84020.
The Balanced Knee System is indicated in the salvage of previously failed surgical attempts where femoral bone loss does not require the use of augments or stem extensions and where collateral ligaments may be relied upon for medial/lateral stability. |
Code Information |
Lot Number 0054891. |
Recalling Firm/ Manufacturer |
Ortho Development Corporation 12187 South Business Park Dr Draper UT 84020
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For Additional Information Contact | 801-619-3450 |
Manufacturer Reason for Recall | Erroneous lot number on 3 of 28 units of Balanced Knee System. Three units from Lot Number 0055245 were mixed in with the recalled lot (0054891). |
FDA Determined Cause 2 | Mixed-up of materials/components |
Action | Consignees were notified via e-mail on May 29, 2009 and June 5, 2009 requesting return of units. Direct questions about the recall to the Ortho Development Corporation by calling 1-801-619-3450. |
Quantity in Commerce | 13 units |
Distribution | Worldwide -- US (states of FL and TX) and 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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