FDAFDA · Food and drugs·Recall number Z-0823-2017
Femoral Integral Shaft & Stem 15x27 HA Coated; Femoral Integral Shaft & Stem 15x30 HA Coated; Femoral Integral Shaft & Stem 30x27 HA Coated; Femoral Integral Shaft & Stem 30x30 HA Coated The product is a component is a systems that is intended for the replacement if diseased or deficient bone around the knee joint, distal femur, proximal femur or total femur bone
Published December 28, 2016 · Recall initiated: December 7, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Stanmore Implants Worldwide Ltd.
- Distributor
- Nationwide Distribution to OH, NE, FL, LA, NY, TX, MS, MD, CT, AL, PA
- Lot
- B10635, B11820, B12776, B10636, B10638, B9866
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United Kingdom
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