Z-1004-2009

Reflection, Microstable Acetabular Liner, REF 71740250, 32mm ID, 50-52 OD, 1 each, sterile EO. Component is a...

Name: Z-1004-2009 Reflection, Microstable Acetabular Liner, REF 71740250, 32mm ID, 50-52 OD, 1 each, sterile EO. Component is a...
Creator: Smith & Nephew Inc
Published: 2008-11-21
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2008-11-21 / Terminated / root cause: manufacturing process

FDA source

Smith & Nephew Inc began a recall of Reflection, Microstable Acetabular Liner, REF 71740250, 32mm ID, 50-52 OD, 1 each, sterile EO. Component is a liner used to hold the femoral head used in total... on 2008-11-21. The reason FDA records is "Liners measuring 28 mm ID and were mismarked as 32 mm". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1004-2009
Status: Terminated
Initiated: 2008-11-21
Posted: 2009-04-21
Terminated: 2011-11-21
Recalling firm: Smith & Nephew, Inc.
Product: Reflection, Microstable Acetabular Liner, REF 71740250, 32mm ID, 50-52 OD, 1 each, sterile EO. Component is a liner used to hold the femoral head used in total hip replacement arthroplasty procedures.
Product code: LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Reason for recall: Liners measuring 28 mm ID and were mismarked as 32 mm.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: All affected Smith & Nephew International Distributors were notified via e-mail dated November 24, 2008. In a letter titled "Urgent: Product Recall Notice - Immediate Action Required", distributors were instructed to immediately notify their accounts concerning the recall. All affected product is to be located and returned to the firm immediately. Direct questions to Smith & Nephew, Inc. by calling 1-901-399-5441.
Quantity in commerce: 19 units
Distribution: International Distribution to Canada, France, Germany and Switzerland.
Product codes and lots: Part Number: 71740250, Lot Numbers: 08FM05400 and 08FM05400B.

Product code LPH

K991026Class IIReflection Crosslinked Uhmwpe Acetabular ComponentsSmith & Nephew, Inc. / cleared 1999-10-22

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)