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U.S. Department of Health and Human Services

Class 2 Device Recall JTS External Drive Unit (JTS Grower Drive)

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  Class 2 Device Recall JTS External Drive Unit (JTS Grower Drive) see related information
Date Initiated by Firm July 04, 2017
Create Date September 05, 2017
Recall Status1 Terminated 3 on February 16, 2021
Recall Number Z-3104-2017
Recall Event ID 77753
510(K)Number K140898  K133152  K092138  
Product Classification Prosthesis, knee, femorotibial, constrained, cemented, metal/polymer - Product Code KRO
Product JTS External Drive Unit

JTS Distal Femoral Extendible Implant Femur is intended for the replacement of diseased or deficient bone in the distal femur.
Code Information Product Code MLE3; Serial No. 907-103, 907-104, 907-119, 907-123, 907-125, 907-126, 907-127, 907-028, 907-237, 907-240, 907-500, 907-501, 907-502, 907-503, 907-504.
Recalling Firm/
Manufacturer		 Stanmore Implants Worldwide Ltd.
Centennial Park
210 Centennial Avenue; CENTENNIAL PARK
Borehamwood United Kingdom
For Additional Information Contact
972-501-1402
Manufacturer Reason
for Recall		 Three (3) complaints were identified in which the potential for utilization of the JTS Grower Drive in the incorrect orientation in relation to the limb entry point of the device, together with the potential to select incorrect settings for the extension procedure. As a result, the prostheses in such cases failed to extend as intended.
FDA Determined
Cause 2		 Labeling design
Action Stanmore Implants sent an Urgent Field Safety Notice dated July 4, 2017, notifying customers of the recall. Additionally, the recalling firm requests that consignees immediately check their inventory for recalled product, quarantine any product on hand, inform SIW of any product on hand, complete the attached response form, and return the response for and affected product to the firm. It is requested that consignees distribute the notice internally to all affected parties and that they contact their local Stanmore representative to request training. If any adverse events are associated with this device, the firm asks that it be reported to them. For further questions, please call (972) 501-1402.
Quantity in Commerce 15 units
Distribution US Distribution to the states of : CA, FL, GA, KS, MI, NJ, OH, PA, SC, and TX.
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 = KRO and Original Applicant = STANMORE IMPLANTS WORLDWIDE LTD.
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