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U.S. Department of Health and Human Services

Class 2 Device Recall Balance Knee System (BKS)

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  Class 2 Device Recall Balance Knee System (BKS) see related information
Date Initiated by Firm May 30, 2019
Create Date May 06, 2020
Recall Status1 Open3, Classified
Recall Number Z-1903-2020
Recall Event ID 85157
510(K)Number K994370  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product Tibial Tray Nonporous A Size 2; Model # PN 162-1200-A; Material: Ti6Al4V.
Code Information Lot Number: A200590
Recalling Firm/
Manufacturer		 Ortho Development Corporation
12187 S Business Park Dr
Draper UT 84020-8663
For Additional Information Contact Ryan Carpenter
800-429-8339
Manufacturer Reason
for Recall		 The locking mechanism of the tibial tray exhibited a manufacturing defect in which a uniform ridge was cut along the inner wall of the "T" and "Y" junctions, which may cause resistance when the Tibial Insert was being assembled.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action The firm notified their US sales managers via teleconference on 07/19/2019. The sales managers coordinated distribution of the notification letter to the distributors and surgeons. All 12 US surgeons received both in-person verbal and written notices (hand delivered by sales reps) subsequent to the 07/19/2019 teleconference meeting. Recall actions for products sold in Japan were coordinated by the firm's parent company. In the firm's "Urgent Advisory Notice/Medical Device Recall Notice", dated 07/16/2019 includes the following instructions for end users: Contacting affected patients should be at the discretion of the surgeon to discuss the risks identified. The surgeon should weigh the risk of removing an implanted device against the risk of leaving it in place. Absence of clinical failure should be considered during the decision-making process. The appropriate action is left to the judgment of the surgeon and the preference of the patient. Complete and return the Customer Acknowledgement form. For any questions or concerns, call 801-553-9991 or contact via email at Ryan_Carpenter@orthodevelopment.com.
Quantity in Commerce 27
Distribution US: CA, FL, OH, PA, TX, and UT. OUS: Japan.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = JWH and Original Applicant = ORTHO DEVELOPMENT CORP.
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