| Class 2 Device Recall REFLECTION(R), MICROSTABLE(R), ACETABULAR LINER | |
Date Initiated by Firm | November 25, 2013 |
Date Posted | December 26, 2013 |
Recall Status1 |
Terminated 3 on February 01, 2017 |
Recall Number | Z-0581-2014 |
Recall Event ID |
67042 |
510(K)Number | K012787 |
Product Classification |
Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
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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 TN 38116
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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 |
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 |
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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 = LPH
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