Conformis, Inc. recalls Conformis iTotal Hip Replacement System: HBS-033-00xx-010101, (HIP-PATIENT SPECIFIC STEM LEFT)

Recall date

March 29, 2019

Source

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

Recall number

Z-1775-2019

FDA classification

Class II

Brand / firm

Conformis, Inc.

Sold / distributed

Nationwide

Why it was recalled

Discrepancy of 3mm between the values displayed and approved by surgeons in iViews as the neck/head lengths and the resulting neck/head lengths in the manufactured implants.

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

What was recalled

Conformis iTotal Hip Replacement System: HBS-033-00xx-010101, (HIP-PATIENT SPECIFIC STEM LEFT)