Z-1290-2021Class II

Corin BIOLOX DELTA MOD HEAD 32mm EX LONG +7mm 12/14 TAPER. Corin Trinity Acetabular System with Extra Long...

Name: Z-1290-2021 Corin BIOLOX DELTA MOD HEAD 32mm EX LONG +7mm 12/14 TAPER. Corin Trinity Acetabular System with Extra Long...
Creator: Corin Ltd
Published: 2021-01-25
License: https://open.fda.gov/license/

Corin Limited / initiated 2021-01-25 / Terminated / root cause: labeling and UDI

FDA source

Corin Ltd began a recall of Corin BIOLOX DELTA MOD HEAD 32mm EX LONG +7mm 12/14 TAPER. Corin Trinity Acetabular System with Extra Long Heads/Trinity Biolox Delta Ceramic Head (Generic... on 2021-01-25. FDA classified it as Class II and gives the reason as "The size indicated on the labeling on the outer packaging, on the inner packaging, and on the patient stickers inside the packaging is incorrect: the Trinity Biolox Delta Ceramix Head 32XL is labeled as 36XL and...". 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-1290-2021
Classification: Class II
Status: Terminated
Initiated: 2021-01-25
Posted: 2021-03-22
Terminated: 2022-11-23
Recalling firm: Corin Limited
Product: Corin BIOLOX DELTA MOD HEAD 32mm EX LONG +7mm 12/14 TAPER. Corin Trinity Acetabular System with Extra Long Heads/Trinity Biolox Delta Ceramic Head (Generic Name: Hip Prosthesis). The Trinity Acetabular System is a modular acetabular cup system consisting of a press fit, titanium alloy shell; acetabular liners in neutral offset, +4mm offset, +4mm oblique, neutral 4mm EPW; and ceramic and CoCrMo modular heads. The ceramic and CoCrMo modular heads are compatible with Corin titanium femoral stems. The Trinity Biolox Ceramic heads are packaged in a double peel pouch configuration.
Product code: MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Reason for recall: The size indicated on the labeling on the outer packaging, on the inner packaging, and on the patient stickers inside the packaging is incorrect: the Trinity Biolox Delta Ceramix Head 32XL is labeled as 36XL and vice-versa.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: The firm contacted their consignee by email on 01/25/2021. The distributor was instructed to identify the affected product in its inventory and return it to Corin USA in order to contain the part. A recall letter will be sent and acknowledgement of receipt will be requested.
Quantity in commerce: 23 units
Distribution: Worldwide distribution - US Nationwide distribution and the countries of Colombia, Poland, Germany, Australia.
Product codes and lots: Model:104.3215/Lot number:464664

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1290-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1290-2021	Class II	Terminated	Voluntary: Firm initiated	2021-03-31	2021-03-22
Z-1291-2021	Class II	Terminated	Voluntary: Firm initiated	2021-03-31	2021-03-22

Product code MEH

K130343Class IICorin Trinity Acetabular System with Extra-Long HeadsCorin USA / cleared 2013-05-28

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)