DePuy Orthopaedics, Inc.: 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

Recalling firm

DePuy Orthopaedics, Inc.

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.

Status

Terminated

Initiated

2012-08-22

Posted

2012-09-20

Terminated

2013-10-09

Reason

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

Labeling Change Control

Action

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.

Quantity

12 liners

Distribution

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

Lot, serial or model codes

Catalogue Lot Number 87-5987 3189424  3312166  3340992  3402685

510(k) numbers

["K071117"]

PMA numbers

not on file

Product code

KWZ

Firm FEI

1818910

Firm city

Warsaw

Firm state

IN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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