JTS External Drive Unit JTS Distal Femoral Extendible recall
JTS External Drive Unit JTS Distal Femoral Extendible Implant Femur is intended for the replacement of diseased or deficient bone in the distal femur.
Why was JTS External Drive Unit JTS Distal Femoral Extendible recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- 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.
- Recalling firm
- Stanmore Implants Worldwide Ltd.
- Quantity
- 15 units
- Distribution
- US Distribution to the states of : CA, FL, GA, KS, MI, NJ, OH, PA, SC, and TX.
- Recall date
- September 13, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)