Corin Trinity Acetabular System Recalled for Incorrect Size Labeling
Corin Ltd is recalling 23 units of the Trinity Acetabular System because the size indicated on the packaging and patient stickers is incorrect.
What this means for you
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, and the hazard is a labeling error regarding size, which fits the rubric criteria for minor labeling errors or low-risk contamination without reported injuries.
Plain-English summary
Corin Ltd is recalling 23 units of the Corin Trinity Acetabular System with Extra Long Heads/Trinity Biolox Delta Ceramic Head. The recall involves the specific model 104.3615 with lot number 464665.
The recall was initiated because the size indicated on the labeling on the outer packaging, inner packaging, and patient stickers inside the packaging is incorrect. Specifically, the Trinity Biolox Delta Ceramix Head 32XL is labeled as 36XL, and vice versa.
The affected units were distributed worldwide, including in the United States, Colombia, Poland, Germany, and Australia. Healthcare providers and patients should verify the size of the implanted or packaged components against the actual physical dimensions rather than relying solely on the printed labels.
The recalled product
- Product
- 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
- Manufacturer
- Corin Ltd
- Hazard
- 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:104.3615/Lot number:464665
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.
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