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U.S. Department of Health and Human Services

Enforcement Report - Week of September 26, 2012

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Event Detail

Event ID 62765
Product Type Devices
Status Ongoing
Recalling Firm DePuy Orthopaedics, Inc.
City Warsaw
State IN
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-08-22
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Nationwide Distribution including the states of MA, TX, OH, CA, and NC.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Catalogue Lot Number 87-5987 3189424 3312166 3340992 3402685 Class II 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. 12 liners Z-2414-2012
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