Z-1928-2013Class II

R3 (TM) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM ID, 62 MM OD, QTY: (1), STERILE H2O2, REF 71335762...

Name: Z-1928-2013 R3 (TM) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM ID, 62 MM OD, QTY: (1), STERILE H2O2, REF 71335762...
Creator: Smith & Nephew Inc
Published: 2013-05-29
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2013-05-29 / Terminated / root cause: packaging

FDA source

Smith & Nephew Inc began a recall of R3 (TM) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM ID, 62 MM OD, QTY: (1), STERILE H2O2, REF 71335762. Orthopaedic on 2013-05-29. FDA classified it as Class II and gives the reason as "One batch of 60 mm 20o R3 XLPE liner may be laser etched and packaged as a 62 mm 20o liner and one batch of 62 mm 20o R3 XLPE liner may be laser etched and packaged as a 60 mm 20o liner". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1928-2013
Classification: Class II
Status: Terminated
Initiated: 2013-05-29
Posted: 2013-08-08
Terminated: 2016-03-22
Recalling firm: Smith & Nephew, Inc.
Product: R3 (TM) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM ID, 62 MM OD, QTY: (1), STERILE H2O2, REF 71335762. Orthopaedic.
Product code: MBL Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
Reason for recall: One batch of 60 mm 20o R3 XLPE liner may be laser etched and packaged as a 62 mm 20o liner and one batch of 62 mm 20o R3 XLPE liner may be laser etched and packaged as a 60 mm 20o liner.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: All affected Smith & Nephew Sales Representatives were notified of problem and the recall via email on 5/29. They were instructed to cease use and distribution of the product and quarantine for return. Surgeons were notified by letter beginning on 6/12. International consignees were notified on 05/29 via email.
Quantity in commerce: 53 units
Distribution: Worldwide Distribution-USA including the states of PA, WA, TX, FL, IA, MI, WI, TN, KY, IN, NY, MO and OR, and the countries of India, Canada, Chile, Venezuela, Dubai, South Africa, Australia, Poland, Romania, Belgium, Germany and United Kingdom.
Product codes and lots: Batch No. 12FM00603

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1928-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1928-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-14	2013-08-08
Z-1929-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-14	2013-08-08

Product code MBL

K113848Class IIR3 Xlpe LinersSmith & Nephew, Inc. / cleared 2012-04-27

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)