Z-0064-2020Class II

iTotal Hip Replacement System, Model HBS-033-0013-020101, Size 13 Hip-Patient Specific Stem Right

Name: Z-0064-2020 iTotal Hip Replacement System, Model HBS-033-0013-020101, Size 13 Hip-Patient Specific Stem Right
Creator: Conformis, Inc.
Published: 2019-08-22
License: https://open.fda.gov/license/

ConforMIS, Inc. / initiated 2019-08-22 / Terminated / root cause: packaging

FDA source

Conformis, Inc. began a recall of iTotal Hip Replacement System, Model HBS-033-0013-020101, Size 13 Hip-Patient Specific Stem Right on 2019-08-22. FDA classified it as Class II and gives the reason as "Two femoral stems, sizes 13 and 15, were erroneously switched and packed in each other's packaging". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0064-2020
Classification: Class II
Status: Terminated
Initiated: 2019-08-22
Posted: 2019-10-08
Terminated: 2020-07-08
Recalling firm: ConforMIS, Inc.
Product: iTotal Hip Replacement System, Model HBS-033-0013-020101, Size 13 Hip-Patient Specific Stem Right
Product code: LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Reason for recall: Two femoral stems, sizes 13 and 15, were erroneously switched and packed in each other's packaging.
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: Conformis was notified of the issue on 8/22/19 when a customer reported that there had been a package mix-up. Conformis immediately contacted the customer associated with the other serial number involved in the mix-up and requested the return of that stem. Conformis is not aware of any other instances of mixed product.
Quantity in commerce: 1
Distribution: Distributed to consignees in MD and NV.
Product codes and lots: 0447621

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0064-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0063-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-16	2019-10-08
Z-0064-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-16	2019-10-08

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)