Lower riskMedical device recall · FDA · Published January 25, 2021
Corin Hip Prosthesis Recalled: Incorrect Size Labeling on Packaging
Corin recalls hip prostheses with incorrect size labeling on packaging, risking improper fit. Affected units have Trinity Biolox Delta Ceramix heads labeled as 36XL instead of 32XL. Consumers should contact Corin for details.
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.
Take action
Contact the company
📍Recalling firmCorin LtdUnit 1-57-8, Corinium Centre · Cirencester, United Kingdom
“Corin Hip Prosthesis Recalled: Incorrect Size Labeling on Packaging.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63348-corin-hip-prosthesis-recalled-incorrect-size-labeling-on-packaging. Based on FDA recall #Z-1290-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1290-2021%22&limit=1).
The FDA announced on Jan. 25, 2021, that Corin Ltd is recalling its Trinity Acetabular System with Extra Long Heads due to incorrect labeling of the ceramic head sizes. The agency said the hazard involves mislabeled outer and inner packaging as well as patient stickers.
How to tell if you have it
Brand: Corin
Product: Corin BIOLOX DELTA MOD HEAD 32mm EX LONG +7mm 12/14 TAPER. Corin Trinity Acetabular System with Extra Long Heads
Model: 104.3215
Lot number: 464664
The hazard
According to the FDA, the size indicated on the labeling on the outer packaging, the inner packaging, and the patient stickers inside the packaging is incorrect. Specifically, the Trinity Biolox Delta Ceramix Head 32XL is labeled as 36XL and vice-versa.
Context
GovInfoNow's records show Corin Ltd has issued seven other recalls since May 6, 2021. Other recent recalls of similar products include the Oct. 13, 2023 Unity CR Femur Right Size 6 labeling mix-up and the Nov. 8, 2022 BIOLOX Delta Head size error. Recent industry recalls with labeling or packaging issues include Grace Medical's April 3, 2026 Stapes Prosthesis recall, Straumann's Aug. 12, 2026 GM Helix Implant dimension mismatch, and Blom-Singer's June 17, 2026 Classic Voice Prosthesis labeling hazard.
How to tell if you have this one
Check for the model number 104.3215 and lot number 464664 on the packaging. The product is a hip prosthesis with a Ceramix head labeled as 36XL instead of 32XL.
Brand
Corin
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
Worldwide distribution - US Nationwide distribution and the countries of Colombia, Poland, Germany, Australia.
Recall number
Product, codes & lots
Z-1290-2021
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.; Model:104.3215/Lot number:464664
Z-1291-2021
Corin BIOLOX DELTA MOD HEAD 36mm EX LONG +8mm12/14 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.; Model:104.3615/Lot number:464665
Based on the official FDA remedy
What to do — step by step
Contact Corin
Reach out to Corin directly for specific details about your product and next steps.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution and the countries of Colombia, Poland, Germany, Australia.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 22 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1290-2021 (January 25, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1290-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.