Z-0731-2019Class II

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

Name: Z-0731-2019 iTotal Hip Replacement System, Total Hip Replacement System, Catalog Number HAA-050-D001-020101
Creator: Conformis, Inc.
Published: 2018-10-16
License: https://open.fda.gov/license/

ConforMIS, Inc. / initiated 2018-10-16 / Terminated

FDA source

Conformis, Inc. began a recall of iTotal Hip Replacement System, Total Hip Replacement System, Catalog Number HAA-050-D001-020101 on 2018-10-16. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0731-2019
Classification: Class II
Status: Terminated
Initiated: 2018-10-16
Posted: 2019-01-12
Terminated: 2020-06-29
Recalling firm: ConforMIS, Inc.
Product: iTotal Hip Replacement System, Total Hip Replacement System, Catalog Number HAA-050-D001-020101
Product code: LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
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.
FDA root cause: Under Investigation by firm
Action: The customer was contacted via email on 10/16/18.
Quantity in commerce: 1
Distribution: The products were distributed to the following US states: TN.
Product codes and lots: Serial Number 0424647

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0731-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0731-2019	Class II	Terminated	Voluntary: Firm initiated	2019-01-23	2019-01-11

Product code LPH

K162719Class IIiTotal® Hip Replacement SystemConformis, Inc. / cleared 2017-06-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)