S-Rom¿ Total Hip System Poly Liner Packaging: The insert is placed… — Class II medical device recall Z-2414-2012
Terminated recall by DePuy Orthopaedics, Inc., reported 2012-09-26, distributed nationwide. Orthopaedics, Inc. (DePuy) is issuing a voluntary recall of four lots of the S-ROM" liner because the Carton l
| Recall number | Z-2414-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DePuy Orthopaedics, Inc., Warsaw, IN, United States |
| Recall initiated | 2012-08-22 |
| Classified | 2012-09-20 |
| Reported by FDA | 2012-09-26 |
| Terminated | 2013-10-09 |
| Distributed | Nationwide (US) |
| Quantity | 12 liners |
| Reason classes | labeling |
| Lot numbers | 3189424, 3312166, 3340992, 3402685, 87-5987 |
| Model numbers | 3189424, 3312166, 3340992, 3402685, 87-5987 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2414-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.