FDA Device recall Z-3104-2017
JTS External Drive Unit JTS Distal Femoral Extendible Implant Femur is intended for the replacement of diseased or deficient bone in the di…
- FDA Device
- Class II
- terminated
- Published 2017-09-13
On 2017-09-13 the FDA classified a Class II recall of JTS External Drive Unit JTS Distal Femoral Extendible Implant Femur is intended for the replacement of diseased or deficient bone in the di… by Stanmore Implants Worldwide, citing 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,….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3104-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-07-04 |
| Published | 2017-09-13 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Stanmore Implants Worldwide |
| Distribution | CA, FL, GA, KS, MI, NJ, OH, PA, SC, TX |
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.
Reason
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.
Identifiers
| code_info | 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,…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Other recalls by Stanmore Implants Worldwide
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FDA Device · Class II · 2016-12-28 · Stanmore Implants Worldwide - DF Coated Integral Shaft & Stem 15x30x38
FDA Device · Class II · 2016-12-28 · Stanmore Implants Worldwide - Femoral Shaft L=120mm
FDA Device · Class II · 2016-12-28 · Stanmore Implants Worldwide - Femoral Integral Shaft & Stem 15x27 HA Coated
FDA Device · Class II · 2016-12-28 · Stanmore Implants Worldwide - Tibial Component Metal Cased Small Long
FDA Device · Class II · 2016-12-28 · Stanmore Implants Worldwide
All Stanmore Implants Worldwide recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3104-2017%22
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