| Class 2 Device Recall R3 (TM) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM ID, 62 MM OD | |
Date Initiated by Firm | May 29, 2013 |
Date Posted | August 08, 2013 |
Recall Status1 |
Terminated 3 on March 22, 2016 |
Recall Number | Z-1929-2013 |
Recall Event ID |
65370 |
510(K)Number | K113848 |
Product Classification |
Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous - Product Code MBL
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Product | R3 (TM) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM ID, 60 MM OD, QTY: (1), STERILE H2O2, REF 71335760.
Orthopaedic. |
Code Information |
Batch No. 12FM00602 |
Recalling Firm/ Manufacturer |
Smith & Nephew Inc 1450 E. Brooks Rd Memphis TN 38116
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For Additional Information Contact | Joe Metzger 978-749-1330 |
Manufacturer 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. |
FDA Determined Cause 2 | 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. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = MBL
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