Z-3104-2017Class II

JTS External Drive Unit JTS Distal Femoral Extendible Implant Femur is intended for the replacement of...

Name: Z-3104-2017 JTS External Drive Unit JTS Distal Femoral Extendible Implant Femur is intended for the replacement of...
Creator: Stanmore Implants Worldwide Ltd.
Published: 2017-07-04
License: https://open.fda.gov/license/

Stanmore Implants Worldwide, Ltd. / initiated 2017-07-04 / Terminated / root cause: labeling and UDI

FDA source

Stanmore Implants Worldwide Ltd. began a recall of JTS External Drive Unit JTS Distal Femoral Extendible Implant Femur is intended for the replacement of diseased or deficient bone in the distal femur on 2017-07-04. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-3104-2017
Classification: Class II
Status: Terminated
Initiated: 2017-07-04
Posted: 2017-09-05
Terminated: 2021-02-16
Recalling firm: Stanmore Implants Worldwide, Ltd.
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.
Product code: KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
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.
Root cause tag: labeling and UDI
FDA root cause: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3104-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3104-2017	Class II	Terminated	Voluntary: Firm initiated	2017-09-13	2017-09-05

Product code KRO

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)