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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Corin USA Limited: Potential for abrasion of the sterile barrier pouches of the new packaging system.

Agency Publication Date: April 22, 2016
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Affected Products

Product: Trinity Acetabular System Product Usage - Total Hip Replacement.

Non Occluded TPS Shell 048mm Taper SZ2, Lot Code: 323741

Lot Numbers:
Code
Product: Trinity Acetabular Shell Product Usage: Total Hip Replacement.

Cluster Shell 044mm Taper Size 1, Lot Code: 320023; Cluster Shell 046mm Pager Size 2, Lot Code: 320018; Cluster Shell 048mm Taper Size 2, Lot Codes: 321691, 322402, 322981, 322982, 323745, 323746, 324298; Cluster Shell 050mm Taper Size 2, Lot Codes: 321954, 322753, 322980; Cluster Shell 050mm Taper Size 3, Lot Codes:

Lot Numbers:
Code
Code
Codes
Codes
Codes
Product: Trinity Acetabular Shell Product Usage Total Hip Replacement.

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.

Lot Numbers:
Codes
Codes

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 73205
Status: Resolved
Manufacturer: Corin USA Limited
Manufactured In: United States
Units Affected: 3 products (629 devices in total)

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.