| Date Initiated by Firm | July 16, 2013 |
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| Date Posted | August 26, 2013 |
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| Recall Status1 |
Terminated 3 on June 04, 2014 |
| Recall Number | Z-2065-2013 |
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| Recall Event ID |
65800 |
| 510(K)Number | K955296 |
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| 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 |
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| 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. |
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FDA Determined
Cause 2 | Device Design |
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| Action | The firm notified their consignees of their product recall by parcel post on 07/16/2013. |
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| Quantity in Commerce | 5 units |
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| Distribution | US Distribution to the state of Tennessee only. |
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| 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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