Trinity Acetabular Shell Product Usage: Total Hip Replacement.
FDA Recall Z-1527-2016 · Posted None
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Recalling FirmCorin USA Limited
Recall StatusTerminated
Product CodeLZO
Date Initiated2016-01-29
Date Terminated2019-12-16
Product Quantity629 devices in total
Reason for Recall
Potential for abrasion of the sterile barrier pouches of the new packaging system.
Firm Action
Corin sent an Urgent Medical Device Recall letter dated February 3, 2016. The letter identified the affected product, problem and actions to be taken. On January 29, 2016, Eight (8) of 11 distributors were spoken to during a Corin National Sales Meeting informing them of the recall. The 3 remaining distributors were notified by phone calls same date. Also, on February 2, 2016 Corin sent a Recall Letter to their Foreign consignee informating them of the recall of the Trinity Acetabular Shell and the actions to be take by the costumers including the return of the Customer Response Form and Contact information as Corin LTD Compliance Director at +44 (0) 1285 649190 Monday thru Friday 8:30am to 5:00pm UK Time
Root Cause
Packaging process control
Distribution Pattern
Worldwide Distribution - US Nationwide in the states of CA, FL, ID, TX, OK, OH, MA, and NC and the countries of Australia Belgium, Egypt, Germany, Ghana, Italy, Japan, Poland, South Africa and UK.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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