Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1290-2021·Announced 2021-03-31

Corin Trinity Hip Prosthesis Heads Recalled for Incorrect Size Labeling

Corin Ltd is recalling 23 units of Trinity Biolox Delta Ceramic Heads due to incorrect size labeling on packaging and patient stickers.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard is a labeling error regarding size, which is a significant defect but does not involve a high-risk pathogen or reported serious injury, fitting the Moderate category for minor labeling errors or low-risk contamination.

Plain-English summary

Corin Ltd is recalling 23 units of the Corin Trinity Acetabular System with Extra Long Heads, specifically the Trinity Biolox Delta Ceramic Heads. The recall involves the 32mm Extra Long +7mm 12/14 Taper model, identified by Lot number 464664. The product is a modular hip prosthesis component distributed worldwide, including in the United States, Colombia, Poland, Germany, and Australia.

The reason for the recall is a labeling error. The size indicated on the outer packaging, inner packaging, and patient stickers is incorrect. Specifically, the Trinity Biolox Delta Ceramix Head 32XL is labeled as 36XL, and the 36XL is labeled as 32XL. This discrepancy could lead to the implantation of an incorrectly sized component.

Healthcare providers and patients who have received or may have received these specific units should contact Corin Ltd for further instructions. The source text does not report any illnesses or injuries associated with this labeling error.

The recalled product

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…
Manufacturer: Corin Ltd
Category: Medical Device — Orthopedic Implant
Hazard: mis-labeling
Affected units: 23

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

Model:104.3215/Lot number:464664

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Corin Ltd under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Corin Ltd

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