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U.S. Department of Health and Human Services

Class 2 Device Recall REFLECTION(R), MICROSTABLE(R), ACETABULAR LINER

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 Class 2 Recall
REFLECTION(R), MICROSTABLE(R), ACETABULAR LINER
see related information
Date Posted December 26, 2013
Recall Status1 Open
Recall Number Z-0581-2014
Recall Event ID 67042
Premarket Notification
510(K) Number
K012787 
Product Classification Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented - Product Code LPH
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.
Code Information Batch No. 12BM04836
Recalling Firm/
Manufacturer
Smith & Nephew Inc
1450 E. Brooks Rd
Memphis, Tennessee 38116
For Additional Information Contact Joe Metzger
978-749-1330
Manufacturer 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 Determined
Cause 2
OTHER/UNDETERMINED: Under Investigation by the firm
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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LPH and Original Applicant = SMITH & NEPHEW, INC.
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