Distal Femoral Replacement (patient specific, custom made orthopedic implant device). PIN 19960
Class I - DangerousWhat Should You Do?
- Check if you have this product: Device Identifier: PIN 19960, Lot: 19960
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Stanmore Implants Worldwide Ltd.
- Reason for Recall:
- Incorrect component used to manufacture distal femoral replacement.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Distal Femoral Replacement (patient specific, custom made orthopedic implant device). PIN 19960
Product Codes/Lot Numbers:
Device Identifier: PIN 19960, Lot: 19960
Distribution:
Distributed in: US, OH
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1623-2016
Related Recalls
JTS External Drive Unit JTS Distal Femoral Extendible Implant Femur is intended for the replacement of diseased or deficient bone in the distal femur.
Stanmore Implants Worldwide
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.
The recalling firm has received 5 customer inquiries reporting that at least one pouch of the double pouch packaging configuration has been punctured by the tip of the device's stem.
The recalling firm has received 5 customer inquiries reporting that at least one pouch of the double pouch packaging configuration has been punctured by the tip of the device's stem.