FDA-Device2016-12-28Class II
Tibial Component Metal Cased Small Long; Tibial Component Metal Cased Small Short; Tibial Component Metal Cased Std Long; Tibial Component Metal Cased Std Short 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
Stanmore Implants Worldwide Ltd.
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.
Sold states
Nationwide Distribution to OH, NE, FL, LA, NY, TX, MS, MD, CT, AL, PA
Affected count
51 units
Manufactured in
210 Centennial Avenue Centennial Park, Centennial Park, Borehamwood, N/A, United Kingdom
Products
Tibial Component Metal Cased Small Long; Tibial Component Metal Cased Small Short; Tibial Component Metal Cased Std Long; Tibial Component Metal Cased Std Short 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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0821-2017Don't want to check this manually?
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