JTS External Drive Unit JTS Distal Femoral Extendible Implant Femur… — Class II medical device recall Z-3104-2017
Terminated recall by Stanmore Implants Worldwide Ltd., reported 2017-09-13, distributed in CA, FL, GA, KS, MI, NJ, OH, PA…. Three (3) complaints were identified in which the potential for utilization of the JTS Grower Drive in the inc
| Recall number | Z-3104-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stanmore Implants Worldwide Ltd., Borehamwood, N/A, United Kingdom |
| Recall initiated | 2017-07-04 |
| Classified | 2017-09-05 |
| Reported by FDA | 2017-09-13 |
| Terminated | 2021-02-16 |
| Distributed | CA, FL, GA, KS, MI, NJ, OH, PA, SC, TX |
| Quantity | 15 units |
| Serial numbers | 907-028, 907-103, 907-104, 907-119, 907-123, 907-125, 907-126, 907-127, 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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3104-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.