Product Name: Hip Arthroplasty System - Hybrid //. Risk class: III (High Risk) //. Technical name: Modular system for total arthroplasty //. Registration number: 10417940085 //. Affected Model (s): Acetabular Insert PHENOM Poly (04.13.13.xxxxx) / Acetabular Insert PHENOM Poly Rear Ceiling (04.13.14.xxxxx) Lot (s): Various //. Products manufactured before 08/25/2016 - Check affected Codes / Batches