Date Initiated by Firm | July 16, 2013 |
Date Posted | August 26, 2013 |
Recall Status1 |
Terminated 3 on June 04, 2014 |
Recall Number | Z-2071-2013 |
Recall Event ID |
65800 |
510(K)Number | K955296 |
Product Classification |
Template - Product Code HWT
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Product | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/20, Stem size 04, prox. Stem dia. 20 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg |
Code Information |
Lots: B209033, B225119 |
Recalling Firm/ Manufacturer |
Waldemar Link GmbH & Co. KG (Corp. Hq.) Barkausenweg 10 Hamburg Germany
|
Manufacturer Reason for Recall | The trial stems were manufactured using the wrong design. |
FDA Determined Cause 2 | Device Design |
Action | The firm notified their consignees of their product recall by parcel post on 07/16/2013. |
Quantity in Commerce | 5 units |
Distribution | US Distribution to the state of Tennessee only. |
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 = HWT
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