Reported May 4, 2016 · Terminated
Trinity Acetabular Shell Product Usage: Total Hip Replacement.
Corin USA Limited
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Corin USA Limited · 5670 W Cypress St Ste C · Tampa, FL · 33607-1774
Is this the product you have?
- Trinity Acetabular Shell Product UsageTotal Hip Replacement
- Lot codes and dates
5 of 5 products
Products covered by this recall # Product as published 1 Cluster Shell 044mm Taper Size 1, Lot Code: 320023 2 Cluster Shell 046mm Pager Size 2, Lot Code: 320018 3 Cluster Shell 048mm Taper Size 2, Lot Codes: 321691, 322402, 322981, 322982, 323745, 323746, 324298 4 Cluster Shell 050mm Taper Size 2, Lot Codes: 321954, 322753, 322980 5 Cluster Shell 050mm Taper Size 3, Lot Codes - Amount recalled
- 629 devices in total
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
Potential for abrasion of the sterile barrier pouches of the new packaging system.
This product could cause temporary or reversible health problems — stop using it.
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