Stanmore JTS Distal Femoral Implant Recalled Due to Extension Failure
Stanmore Implants Worldwide Ltd. is recalling 15 JTS Distal Femoral Extendible Implants because they may fail to extend as intended due to incorrect orientation or settings.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the source describes a functional failure of the implant (failure to extend) without reporting hospitalizations, deaths, or serious injuries, fitting the criteria for a high-risk product where injury has not yet been reported.
Plain-English summary
Stanmore Implants Worldwide Ltd. is recalling 15 units of the JTS Distal Femoral Extendible Implant Femur. This medical device is intended for the replacement of diseased or deficient bone in the distal femur. The recall involves Product Code MLE3 with specific serial numbers listed in the agency record.
The recall was initiated after three complaints identified a potential for the JTS Grower Drive to be utilized in the incorrect orientation relative to the limb entry point. Additionally, there was a potential to select incorrect settings for the extension procedure. As a result of these issues, the prostheses failed to extend as intended in the reported cases.
The affected units were distributed in the United States to the states of California, Florida, Georgia, Kansas, Michigan, New Jersey, Ohio, Pennsylvania, South Carolina, and Texas. Healthcare providers and patients should contact the recalling firm for further instructions on how to proceed with the recall.
The recalled product
- 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.
- Manufacturer
- Stanmore Implants Worldwide Ltd.
- Affected units
- 15
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (16)
- 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.
Distribution
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