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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/
Medtronic Sofamor Danek USA Inc
1800 Pyramid Pl
Memphis TN 38132-1703
For Additional Information Contact Eric Epperson
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