Z-3104-2017 Class II Terminated
FDA device recall Z-3104-2017 was initiated by Stanmore Implants Worldwide Ltd. on July 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 p… The recall status is terminated (terminated February 16, 2021). Affected quantity: 15 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 13, 2017
- Initiation Date
- July 4, 2017
- Termination Date
- February 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.