device · product 1 of 1
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.
- Recall number
- Z-2414-2012
- Initiated
- August 22, 2012
- Classification
- Class II
- Status
- Terminated
- Recalling firm
- DePuy Orthopaedics, Inc.
- Quantity
- 12 liners
App-derived interpretation
Labeling or packaging
label has an Incorrect
Official device-enrichment evidence · Sourced
Labeling Change Control
Inspect official wording and provenance
Reason for recall
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.
Code information
Catalogue Lot Number 87-5987 3189424 3312166 3340992 3402685
Distribution pattern
Nationwide Distribution including the states of MA, TX, OH, CA, and NC.