Corin Trinity Acetabular Shell Recall Due to Packaging Abrasion Risk
Corin USA Limited is recalling 629 Trinity Acetabular Shells used in total hip replacements because the new packaging system may abrade the sterile barrier pouches.
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) that could compromise sterility, but no specific injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Corin USA Limited is recalling 629 units of the Trinity Acetabular Shell, 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 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. The specific lots involved include No Hole Shell 048mm Taper Size 2 (Lot Codes: 322986, 323743, 320026, 322977, 323744) and No Hole Shell 052mm Taper Size 3 (Lot Codes: 322396, 322971, 322403, 322984, 322985, 323750).
Healthcare providers and patients should check their device lot numbers against the list provided by the manufacturer. If a device is affected, it should be removed from use and returned to Corin USA Limited for evaluation or replacement.
The recalled product
- Product
- Trinity Acetabular Shell 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 (13)
- No Hole Shell 048mm Taper Size 2
- Lot Codes: 322986
- 323743
- 320026
- 322977
- 323744
- No Hole Shell 052mm Taper Size 3
- Lot Codes: 322396
- 322971
- 322403
- 322984
- 322985
- 323750.
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 System Recalled for Packaging Abrasion Risk
FDA (Devices) · 2016-05-04
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