Z-0475-2021Class II

iTotal Hip Replacement System, Model number HAA-050-D020-020102 The Conformis Hip System includes standard...

Name: Z-0475-2021 iTotal Hip Replacement System, Model number HAA-050-D020-020102 The Conformis Hip System includes standard...
Creator: Conformis, Inc.
Published: 2020-09-21
License: https://open.fda.gov/license/

ConforMIS, Inc. / initiated 2020-09-21 / Terminated / root cause: manufacturing process

FDA source

Conformis, Inc. began a recall of iTotal Hip Replacement System, Model number HAA-050-D020-020102 The Conformis Hip System includes standard hip replacement components as well as the following... on 2020-09-21. FDA classified it as Class II and gives the reason as "Incorrect hip components were provided in kits". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0475-2021
Classification: Class II
Status: Terminated
Initiated: 2020-09-21
Posted: 2020-11-20
Terminated: 2023-06-12
Recalling firm: ConforMIS, Inc.
Product: iTotal Hip Replacement System, Model number HAA-050-D020-020102 The Conformis Hip System includes standard hip replacement components as well as the following patient specific components: femoral stem and single use instrumentation.
Product code: LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Reason for recall: Incorrect hip components were provided in kits.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm received complaints regarding the mix-up of serial numbers on September 11, 2020, and September 21, 2020, from a sales representative who reported that the incorrect iView bearing serial number 0469255 was provided in the kit for serial number 0469225, and that the incorrect iJigs bearing serial number 0469225 were provided in the kit for serial number 0469255. One of the kits was used, while the other was returned to the firm. The firm reported that the co-mingle only involved these two kits. Upon notification of the issue, the firm implemented a planned deviation to verify that there were no other occurrences of the issue. All components were found to be associated with the correct serial number. If you have any questions, contact Director, Regulatory Affairs at 781-345-9001 or email: [email protected].
Quantity in commerce: 2
Distribution: US Distribution in CA.
Product codes and lots: Serial numbers 0469255, 0469255

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0475-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0475-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-02	2020-11-20

Product code LPH

K192198Class IIConformis Hip SystemConformis, Inc. / cleared 2019-11-06

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)