Z-1509-2022Class II

Corin METAFIX HIP STEM, SIZE 3, STANDARD, 135 degrees, COLLARED HIP STEM, CEMENTLESS, Part Number 579.0103

Name: Z-1509-2022 Corin METAFIX HIP STEM, SIZE 3, STANDARD, 135 degrees, COLLARED HIP STEM, CEMENTLESS, Part Number 579.0103
Creator: Corin Ltd
Published: 2022-07-22
License: https://open.fda.gov/license/

Corin Limited / initiated 2022-07-22 / Open, Classified / root cause: manufacturing process

FDA source

Corin Ltd began a recall of Corin METAFIX HIP STEM, SIZE 3, STANDARD, 135 degrees, COLLARED HIP STEM, CEMENTLESS, Part Number 579.0103 on 2022-07-22. FDA classified it as Class II and gives the reason as "One MetaFix size 7 collarless stem from batch 478179 which was incorrectly labelled as a MetaFix size 3 collared stem from batch 485630". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1509-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-07-22
Posted: 2022-08-09
Recalling firm: Corin Limited
Product: Corin METAFIX HIP STEM, SIZE 3, STANDARD, 135 degrees, COLLARED HIP STEM, CEMENTLESS, Part Number 579.0103
Product code: JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Reason for recall: One MetaFix size 7 collarless stem from batch 478179 which was incorrectly labelled as a MetaFix size 3 collared stem from batch 485630.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm notified its direct consignees of the recall on 07/22/2022 by letter. The notice explained the issue and requested the following actions: "Actions to be taken by the Customer: - Quarantine the devices if not yet performed - Return the devices to Corin Limited, displaying the RGA note on the exterior of the parcel, to: RA/Vigilance Department; Corin Ltd; Corinium Centre; Cirencester; Gloucestershire; GL7 1YJ, United-Kingdom - Complete the acknowledgement of receipt and forward it to the Vigilance department of Corin UK to confirm receipt of this Field Safety Notice/Recall letter."
Quantity in commerce: 5 devices
Distribution: US Nationwide distribution in the states of OK, TX, FL.
Product codes and lots: UDI (01) 0 505563 89123 0 (10) 485630 (17) 261114, Lot Number 485630

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1509-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1509-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-17	2022-08-09

Product code JDI

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)