Z-1850-2021Class II

Corin TriIFit TS SIZE 2, STANDARD TAPERED STEM, CEMENTLESS, REF 694.0002. Hip prosthesis component

Name: Z-1850-2021 Corin TriIFit TS SIZE 2, STANDARD TAPERED STEM, CEMENTLESS, REF 694.0002. Hip prosthesis component
Creator: Corin Ltd
Published: 2021-05-06
License: https://open.fda.gov/license/

Corin Limited / initiated 2021-05-06 / Terminated / root cause: labeling and UDI

FDA source

Corin Ltd began a recall of Corin TriIFit TS SIZE 2, STANDARD TAPERED STEM, CEMENTLESS, REF 694.0002. Hip prosthesis component on 2021-05-06. FDA classified it as Class II and gives the reason as "Units from one batch of TriFit TS size 2 stem were found to be labeled as a TriFit CF size 7 stem. And vice versa". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1850-2021
Classification: Class II
Status: Terminated
Initiated: 2021-05-06
Posted: 2021-06-11
Terminated: 2023-07-05
Recalling firm: Corin Limited
Product: Corin TriIFit TS SIZE 2, STANDARD TAPERED STEM, CEMENTLESS, REF 694.0002. Hip prosthesis component.
Product code: MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Reason for recall: Units from one batch of TriFit TS size 2 stem were found to be labeled as a TriFit CF size 7 stem. And vice versa.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: Corin initiated the recall by email on 05/06/2021 and followed with a letter on 05/07/2021 disseminated by email. The firm is seeking the return of the product.
Quantity in commerce: 4 units
Distribution: US Nationwide distribution in the state of TX.
Product codes and lots: Lot Number 465498

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1850-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1850-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-23	2021-06-11
Z-1851-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-23	2021-06-11

Product code MEH

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)