S-Rom¿ Total Hip System Poly Liner Packaging: The insert is placed into an inner foil pouch and vacuum sealed; a ring is placed into a Tyvek/PET pouch and sealed; the foil pouch and Tyvek/PET pouch are placed into a nylon outer pouch and sealed. This is then placed into a folding carton, labeled, and shrink-wrapped. Description: Total Hip System Poly Dial¿ Liner is part of the S-ROM¿ Total Hip System. The Liner is fitted inside the acetabular shell; and is the bearing surface for the He

Product Description

S-Rom¿ Total Hip System Poly Liner Packaging: The insert is placed into an inner foil pouch and vacuum sealed; a ring is placed into a Tyvek/PET pouch and sealed; the foil pouch and Tyvek/PET pouch are placed into a nylon outer pouch and sealed. This is then placed into a folding carton, labeled, and shrink-wrapped. Description: Total Hip System Poly Dial¿ Liner is part of the S-ROM¿ Total Hip System. The Liner is fitted inside the acetabular shell; and is the bearing surface for the Head on the S-ROM¿ stem. The S-ROM liner is used for total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Intended Use: Total Hip System Poly Dial Liner is part of the S-Rom Total Hip System. The Liner is fitted inside the acetabular shell; and is the bearing surface for the Head on the S-Rom¿ stem. The S Rom liner is used for total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.

Details

Recalling Firm

DePuy Orthopaedics, Inc.

Units Affected

12 liners

Distribution

Nationwide Distribution including the states of MA, TX, OH, CA, and NC.

Location

Warsaw, IN