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Class 2 Device Recall JTS External Drive Unit (JTS Grower Drive) |
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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
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Product Classification |
Prosthesis, knee, femorotibial, constrained, cemented, metal/polymer - Product Code KRO
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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
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For Additional Information Contact |
972-501-1402
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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.
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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
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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 = KRO and Original Applicant = STANMORE IMPLANTS WORLDWIDE LTD.
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