Distributed in FL, NJ, NY, OH, OK, RI, TN, VA and HI.
Descripción del producto
Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated, 54mm, O.D. (Acetabular Cup), Catalog Number 140-01-54; For use in primary total hip arthroplasty.
Hip resurfacing implants. Adept acetabular cups manufactured by Finsbury Orthopaedics (see appendix for affected lot codes).
Adept acetabular cups (48mm and 52mm).
Affected UK lot codes (see appendix).
Hip resurfacing implants. Birmingham Hip Resurfacing (BHR) acetabular cups manufactured by Smith & Nephew Orthopaedics Ltd (see Appendix for affected lot numbers in pdf only).
BHR acetabular cups (46mm, 48mm, 50mm, 52mm, 54mm, 56mm, 58mm, 60mm, 62mm, 64mm).
Affected UK lot numbers (see Appendix in pdf only).
ABG I Uncemented Acetabular Cups for Total Hip Replacement
Approximately 3200 ABG I acetabular cups manufactured by Benoist Girard and distributed by Howmedica International Ltd (both part of Pfizer Medical Technology Group) from 1990 until 4th December 1998 and 61 ABG I acetabular cups distributed by Stryker UK Ltd from 5th December 1998 until 2000, including all of the following components:
ABG I acetabular shells, catalogue number 4840-00XX
ABG I acetabular cup liners, catalogue umbers 4840-YYXX and 4841-YYXX
(where XX and YY correspond to the outer and inner diameters in millimetres).
ABG II cups are
not
affected by this Medical Device Alert. See Appendix for further details.