FDA-Device2022-09-07Class II
TaperFit Stem, Size 0, 38mm OFFSET, 12/14 Taper + 188.550 Centraliser, For Cemented Use, REF 588.3800. Orthopedic hip implant component.
Corin Ltd
Hazard
Some of the devices did not pass fatigue testing.
Sold states
Distribution was made to NJ. There was no military/government distribution.
Affected count
1
Manufactured in
Unit 1-57-8, Corinium Centre, Cirencester, United Kingdom
Products
TaperFit Stem, Size 0, 38mm OFFSET, 12/14 Taper + 188.550 Centraliser, For Cemented Use, REF 588.3800. Orthopedic hip implant component.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1667-2022Don't want to check this manually?
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