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Terminated

iTotal Hip Replacement System, Total Hip Replacement System, Catalog Number HAA-050-D001-020101

FDA Recall Z-0731-2019 · Posted None

Recalling FirmConformis, Inc.
Recall StatusTerminated
Product CodeLPH
Date Initiated2018-10-16
Date Terminated2020-06-29
Product Quantity1

Reason for Recall

The stage 1 and 2 reamer instruments used to prepare fixation for the cup in the acetabulum had a -1mm interference fit with acetabulum bone. The expected interference fit is -2mm.

Firm Action

The customer was contacted via email on 10/16/18.

Root Cause

Under Investigation by firm

Distribution Pattern

The products were distributed to the following US states: TN.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K162719iTotal® Hip Replacement SystemConformis, Inc. · 2017-06-14

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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