Femoral Shaft L=120mm; Femoral Shaft L=135mm; Femoral Shaft L=150mm The product is a component i...
FDA Recall #Z-0822-2017 — Class II — December 7, 2016
Product Description
Femoral Shaft L=120mm; Femoral Shaft L=135mm; Femoral Shaft L=150mm 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
Reason for Recall
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.
Recalling Firm
Stanmore Implants Worldwide Ltd. — Borehamwood, N/A
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
11 units
Distribution
Nationwide Distribution to OH, NE, FL, LA, NY, TX, MS, MD, CT, AL, PA
Code Information
B10191, B10443, B9920, B10561, B9921, B9922
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated