Z-2414-2012Class II

S-Rom Total Hip System Poly Liner Packaging: The insert is placed into an inner foil pouch and vacuum sealed...

Name: Z-2414-2012 S-Rom Total Hip System Poly Liner Packaging: The insert is placed into an inner foil pouch and vacuum sealed...
Creator: DePuy Orthopaedics, Inc.
Published: 2012-08-22
License: https://open.fda.gov/license/

Depuy Orthopaedics Inc. / initiated 2012-08-22 / Terminated / root cause: labeling and UDI

FDA source

DePuy Orthopaedics, Inc. began a recall of 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... on 2012-08-22. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2414-2012
Classification: Class II
Status: Terminated
Initiated: 2012-08-22
Posted: 2012-09-20
Terminated: 2013-10-09
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.
Product code: KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
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.
Root cause tag: labeling and UDI
FDA 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 in commerce: 12 liners
Distribution: Nationwide Distribution including the states of MA, TX, OH, CA, and NC.
Product codes and lots: Catalogue Lot Number 87-5987 3189424 3312166 3340992 3402685

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2414-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2414-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-26	2012-09-20

Product code KWZ

K071117Class IIModification to Pinnacle Constrained Acetabular LinersDePuy Orthopaedics, Inc. / cleared 2007-05-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)