FDA Device

Trinity Acetabular System Product Usage - Total Hip Replacement.

Hazard

Potential for abrasion of the sterile barrier pouches of the new packaging system.

What You Should Do

Remedy

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

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Products

Trinity Acetabular System Product Usage - Total Hip Replacement.
Brand
Corin USA Limited
UPC
Non Occluded TPS Shell 048mm Taper SZ2, Lot Code: 323741

Units Affected

629 devices in total

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