Smith & Nephew Inc: Medical Device Recall in 2013 - (Recall #: Z-1928-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: May 29, 2013

Date Posted: August 14, 2013

Recall Number: Z-1928-2013

Event ID: 65370

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.

Status: Terminated

Product Quantity: 53 units

Code Information:

Batch No. 12FM00603

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated