Z-3104-2017 Class II Terminated
FDA device recall Z-3104-2017 was initiated by Stanmore Implants Worldwide Ltd. on Jul 4, 2017 and is designated Class II. 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… The recall status is terminated (terminated Feb 16, 2021). Affected quantity: 15 units.
Recall details
- Product Type
- Devices
- Report Date
- Sep 13, 2017
- Initiation Date
- Jul 4, 2017
- Termination Date
- Feb 16, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15 units
Product description
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 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.
Distribution pattern
US Distribution to the states of : CA, FL, GA, KS, MI, NJ, OH, PA, SC, and TX.
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.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-3104-2017
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026