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U.S. Department of Health and Human Services

Enforcement Report - Week of August 14, 2013

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Event Detail

Event ID 65370
Product Type Devices
Status Ongoing
Recalling Firm Smith & Nephew Inc
City Memphis
State TN
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-05-29
Initial Firm Notification of
Consignee or Public
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
R3 (TM) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM ID, 60 MM OD, QTY: (1), STERILE H2O2, REF 71335760. Orthopaedic. Batch No. 12FM00602 Class II 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. 53 units Z-1929-2013
R3 (TM) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM ID, 62 MM OD, QTY: (1), STERILE H2O2, REF 71335762. Orthopaedic. Batch No. 12FM00603 Class II 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. 53 units Z-1928-2013
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