| Date Initiated by Firm | May 22, 2017 |
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| Create Date | January 24, 2018 |
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| Recall Status1 |
Terminated 3 on August 30, 2018 |
| Recall Number | Z-0410-2018 |
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| Recall Event ID |
78349 |
| 510(K)Number | K073095 |
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| Product Classification |
Marker, radiographic, implantable - Product Code NEU
|
| Product | TUMARK Q, Length 12 cm, Diameter 18G, GTIN 04250195603081, REF 271500, STERILE |
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| Code Information |
Lot numbers: 47883, 47910 & 47911 |
Recalling Firm/
Manufacturer |
Somatex Medical Technologies GmbH
Rheinstr. 7 d
Teltow Germany
|
Manufacturer Reason
for Recall | There is a potential risk of puncture to the packaging material which can compromise the devices sterility, making it non-sterile. |
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FDA Determined
Cause 2 | Device Design |
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| Action | On May 22, 2017, Somatex Medical Technologies distributed notices to their customers advising them of the reason for recall. Customers are advised to inspect stock, quarantine and not use affected product. Products will be exchanged free of charge and a replacement delivery will be arranged promptly. All customers are expected to complete and return the response form via fax. |
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| Distribution | NY - Only one US distributor |
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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 = NEU
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