Corin Ltd recalls TaperFit Stem, Size 0, 38mm OFFSET, 12/14 Taper + 188.550 Centraliser, For Cemented Use, REF 588.3800. Orthopedic hip i…

Recall date

July 12, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1667-2022

FDA classification

Class II

Brand / firm

Corin Ltd

Sold / distributed

Distribution was made to NJ. There was no military/government distribution.

Why it was recalled

Some of the devices did not pass fatigue testing.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

TaperFit Stem, Size 0, 38mm OFFSET, 12/14 Taper + 188.550 Centraliser, For Cemented Use, REF 588.3800. Orthopedic hip implant component.