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U.S. Department of Health and Human Services

Class 2 Device Recall TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS

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  Class 2 Device Recall TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS see related information
Date Initiated by Firm July 16, 2013
Date Posted August 26, 2013
Recall Status1 Terminated 3 on June 04, 2014
Recall Number Z-2065-2013
Recall Event ID 65800
510(K)Number K955296  
Product Classification Template - Product Code HWT
Product TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/22, Stem size 005, prox. Stem dia. 22.5 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
Code Information Lots: B208034
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
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.
510(K) Database 510(K)s with Product Code = HWT and Original Applicant = LINK AMERICA, INC.
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