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Stanmore Implants Worldwide Ltd. recalls DF Coated Integral Shaft & Stem 15x30x38; DF Coated Integral Shaft & Stem 15x36x44; DF Coated Integral Shaft & Ste
Recalled December 28, 2016 · FDA recall Z-0824-2017 · Stanmore Implants Worldwide
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. · FDA Class II
Units
15 units
Sold at
Nationwide Distribution to OH, NE, FL, LA, NY, TX, MS, MD, CT, AL, PA
Description
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.
Product
DF Coated Integral Shaft & Stem 15x30x38; DF Coated Integral Shaft & Stem 15x36x44; DF Coated Integral Shaft & Stem 30x30x38; DF Coated Integral Shaft & Stem 30x36x44 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
Manufacturer(s)
Stanmore Implants Worldwide Ltd.
Made in
United Kingdom
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →