FDA-Device2016-05-18Class II

Distal Femoral Replacement (patient specific, custom made orthopedic implant device). PIN 19960

Stanmore Implants Worldwide Ltd.
Hazard

Incorrect component used to manufacture distal femoral replacement.

Sold states
US distribution to OH.
Affected count
1
Manufactured in
210 Centennial Avenue Centennial Park, Centennial Park, Borehamwood, N/A, United Kingdom
Products
Distal Femoral Replacement (patient specific, custom made orthopedic implant device). PIN 19960

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1623-2016

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