FDA Medical Device Recalls (openFDA)
Stanmore Implants Worldwide Ltd.: JTS External Drive Unit JTS Distal Femoral Extendible Implant Femur is intended for the replacement of diseased or deficient bone in the distal femur.
- Recall number
- Z-3104-2017
- Recalling firm
- Stanmore Implants Worldwide Ltd.
- 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.
- Status
- Terminated
- Initiated
- 2017-07-04
- Posted
- not on file
- Terminated
- 2021-02-16
- 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.
- Root cause
- Labeling design
- Action
- Stanmore Implants sent an Urgent Field Safety Notice dated July 4, 2017, notifying customers of the recall. Additionally, the recalling firm requests that consignees immediately check their inventory for recalled product, quarantine any product on hand, inform SIW of any product on hand, complete the attached response form, and return the response for and affected product to the firm. It is requested that consignees distribute the notice internally to all affected parties and that they contact their local Stanmore representative to request training. If any adverse events are associated with this device, the firm asks that it be reported to them. For further questions, please call (972) 501-1402.
- Quantity
- 15 units
- Distribution
- US Distribution to the states of : CA, FL, GA, KS, MI, NJ, OH, PA, SC, and TX.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K092138","K133152","K140898"]
- PMA numbers
- not on file
- Product code
- KRO
- Firm FEI
- 3004105610
- Firm city
- Borehamwood
- Firm state
- Centennial Park
- Firm country
- United Kingdom
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28