Recall Z-3104-2017— Stanmore Implants Worldwide Ltd.
Class II · Terminated
Class II FDA medical device recall by Stanmore Implants Worldwide Ltd., initiated 2017-07-04, terminated 2021-02-16. It names 3 FDA 510(k) clearances: K140898, K133152, K092138. 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: 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..
- Recalling firm
- Stanmore Implants Worldwide Ltd.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-07-04
- Terminated
- 2021-02-16
- Firm location
- Borehamwood, N/A, United Kingdom
510(k) clearances named in this recall
3 on FDA's record- K140898 — PATIENT SPECIFIC DISTAL FEMORAL
- K133152 — JTS EXTENDIBLE DISTAL FEMORAL IMPLANT
- K092138 — JTS EXTENDEABLE IMPLANT
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.