—#111673

Product

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.

FDA product code: KWZ — Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K071117
Affected lot / code info: Catalogue Lot Number 87-5987 3189424 3312166 3340992 3402685

Why it was recalled

Orthopaedics, Inc. (DePuy) is issuing a voluntary recall of four lots of the S-ROM" liner because the Carton label has an Incorrect Color Code Series Designation. We have received one complaint regarding this issue.

Root cause (FDA determination)

Labeling Change Control

Action the firm took

DePuy sent an "URGENT INFORMATION-MEDICAL DEVICE RECALL NOTICE" dated August 22, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. A Reconciliation Form was included in the letter for customers to complete and return via fax to 574-371-4939. Contact your local Depuy Orthopaedics sales representative for questions related to this recall.

Recalling firm

Firm: DePuy Orthopaedics, Inc.
Address: 700 Orthopaedic Dr, Warsaw, Indiana 46582-3994

Distribution

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

Timeline

Recall initiated: 2012-08-22
Posted by FDA: 2012-09-20
Terminated: 2013-10-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #111673. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.