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U.S. Department of Health and Human Services

Class 2 Device Recall TIBIAL TRAY , SIZE 4, REF 90SRK200400

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  Class 2 Device Recall TIBIAL TRAY , SIZE 4, REF 90SRK200400 see related information
Date Initiated by Firm July 18, 2016
Create Date August 23, 2016
Recall Status1 Terminated 3 on November 22, 2016
Recall Number Z-2637-2016
Recall Event ID 74850
510(K)Number K150496  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product TIBIAL TRAY , SIZE 4, REF 90-SRK-200400, QTY: 1, STERILE R, Responsive Orthopedics, total knee replacement
Code Information P239168, P239169
Recalling Firm/
Manufacturer		 Medtronic Sofamor Danek USA Inc
1800 Pyramid Pl
Memphis TN 38132-1703
For Additional Information Contact Eric Epperson
901-344-1435
Manufacturer Reason
for Recall		 The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.
FDA Determined
Cause 2		 Employee error
Action On 07/18/2016, the firm initiated the correction by verbally notifying (by visit and telephone) three of four (3 of 4) implanting surgeons; the fourth implanting surgeon was verbally notified on 07/25/2016. The firm followed with a letter to all four (4) surgeons on 07/28/2016. Medtronic recommended that the condition of the patients receiving the subject part be assessed for any indications of premature failure during normal post-operative follow-up visits.
Quantity in Commerce 2 units
Distribution AR, MN,MA
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JWH and Original Applicant = Responsive Orthopedics LLC
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