Z-0726-2023Class II

Corin BIOLOX DELTA MOD HEAD,032mm, EX LONG +7mm, REF 104.3215

Name: Z-0726-2023 Corin BIOLOX DELTA MOD HEAD,032mm, EX LONG +7mm, REF 104.3215
Creator: Corin Ltd
Published: 2022-11-08
License: https://open.fda.gov/license/

Corin Limited / initiated 2022-11-08 / Open, Classified / root cause: labeling and UDI

FDA source

Corin Ltd began a recall of Corin BIOLOX DELTA MOD HEAD,032mm, EX LONG +7mm, REF 104.3215 on 2022-11-08. FDA classified it as Class II and gives the reason as "The BIOLOX Delta Ceramic Head size 36XL is labelled as the size 32XL and vice-versa". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0726-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-11-08
Posted: 2022-12-19
Recalling firm: Corin Limited
Product: Corin BIOLOX DELTA MOD HEAD,032mm, EX LONG +7mm, REF 104.3215
Product code: LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Reason for recall: The BIOLOX Delta Ceramic Head size 36XL is labelled as the size 32XL and vice-versa.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: The firm issued a FIELD SAFETY NOTICE/RECALL LETTER on 11/08/2022 by email. The notice explained the issue, potential risk to health, and post implantation recommendations. The following actions were requested: - Return the device from the filed to Coring USA Limited, Paramount Drive, Raynham, MA 02767, USA - Complete the acknowledgment of receipt and forward to [email protected] to confirm receipt of the Field Safety Notice/Recall Letter. For further information concerning this event, contact: [email protected]
Quantity in commerce: 5 units
Distribution: US Nationwide distribution in the states of FL, GA, MA, MI, Ok, PA, TX.
Product codes and lots: UDI/DI (01) 0 5055196 96833 2, Lot 503150

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0726-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0726-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-28	2022-12-19
Z-0727-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-28	2022-12-19

Product code LZO

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)