Z-0581-2014Class II

REFLECTION(R), MICROSTABLE(R), ACETABULAR LINER, 20o OVERHANG, 28 MM ID, 54-56 OD, QTY: (1), STERILE EO, REF...

Name: Z-0581-2014 REFLECTION(R), MICROSTABLE(R), ACETABULAR LINER, 20o OVERHANG, 28 MM ID, 54-56 OD, QTY: (1), STERILE EO, REF...
Creator: Smith & Nephew Inc
Published: 2013-11-25
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2013-11-25 / Terminated

FDA source

Smith & Nephew Inc began a recall of REFLECTION(R), MICROSTABLE(R), ACETABULAR LINER, 20o OVERHANG, 28 MM ID, 54-56 OD, QTY: (1), STERILE EO, REF 71742854, Smith & Nephew, Inc. Memphis, TN 38116... on 2013-11-25. FDA classified it as Class II and gives the reason as "One batch of the Reflection(TM) Polyethylene Acetabular Liners may be out of tolerance causing the liner not to fully seat into the shell". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0581-2014
Classification: Class II
Status: Terminated
Initiated: 2013-11-25
Posted: 2013-12-26
Terminated: 2017-02-01
Recalling firm: Smith & Nephew, Inc.
Product: REFLECTION(R), MICROSTABLE(R), ACETABULAR LINER, 20o OVERHANG, 28 MM ID, 54-56 OD, QTY: (1), STERILE EO, REF 71742854, Smith & Nephew, Inc. Memphis, TN 38116 USA. Orthopaedic.
Product code: LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Reason for recall: One batch of the Reflection(TM) Polyethylene Acetabular Liners may be out of tolerance causing the liner not to fully seat into the shell.
FDA root cause: Other
Action: All affected sales staff was notified of problem and the recall via email on 11/25/2013. There were no US hospitals affected by this recall.
Quantity in commerce: 38 units
Distribution: Distributed in China and Spain.
Product codes and lots: Batch No. 12BM04836

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0581-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0581-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-01	2013-12-26

Product code LPH

K012787Class IIVaporized Hydrogen Peroxide (Vhp) Sterilization of Uhmwpe Components in the Reflection Actabular System (Acetabular LineSmith & Nephew, Inc. / cleared 2002-03-15

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)