Corin Trinity Acetabular System Recalled for Packaging Abrasion Risk
Corin USA Limited is recalling 629 Trinity Acetabular System devices due to potential abrasion of sterile barrier pouches in the new packaging system.
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, and the hazard involves a potential packaging defect (abrasion) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Corin USA Limited is recalling 629 units of the Trinity Acetabular System, a medical device used for total hip replacement. The recall is due to a potential for abrasion of the sterile barrier pouches associated with the new packaging system.
The affected devices are identified by the code Non Occluded TPS Shell 048mm Taper SZ2, Lot Code 323741. These devices were distributed worldwide, including in the United States (California, Florida, Idaho, Texas, Oklahoma, Ohio, Massachusetts, and North Carolina) and in Australia, Belgium, Egypt, Germany, Ghana, Italy, Japan, Poland, South Africa, and the United Kingdom.
Healthcare providers and patients should contact Corin USA Limited for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- Trinity Acetabular System Product Usage - Total Hip Replacement.
- Manufacturer
- Corin USA Limited
- Affected units
- 629
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 (2)
- Non Occluded TPS Shell 048mm Taper SZ2
- Lot Code: 323741
Distribution
Part of a larger recall action
This product is one of 3 recalled by Corin USA Limited 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 3 products in this recall →Related recalls
Same manufacturer · Corin USA Limited
See all →- ModerateCorin Trinity Acetabular Shell Recalled for Packaging Abrasion Risk
FDA (Devices) · 2016-05-04
- ModerateCorin Trinity Acetabular Shell Recall Due to Packaging Abrasion Risk
FDA (Devices) · 2016-05-04
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