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U.S. Department of Health and Human Services

Class 2 Device Recall Tuflex and Tuflex Premium

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 Class 2 Device Recall Tuflex and Tuflex Premiumsee related information
Date Initiated by FirmFebruary 03, 2021
Create DateMarch 10, 2021
Recall Status1 Terminated 3 on January 13, 2022
Recall NumberZ-1200-2021
Recall Event ID 87317
Product Classification Needle, tumor localization - Product Code MIJ
ProductThread-like wire marker
Code Information Tuflex: REF 271640 Affected Lots: 51268, 51414; REF 271641 Affected Lots: 51269, 51410; REF 271642 Affected Lots: 51270, 51411; REF 271643 Affected Lots: 51271, 51412. Tuflex Premium: REF 271650 Affected Lots: 51300; REF 271651 Affected Lots: 51299, 51413; REF 271652 Affected Lots: 51301. 
Recalling Firm/
Manufacturer		 Somatex Medical Technologies GMBH
Hohenzollerndamm 150-151
Berlin Germany
For Additional Information ContactChristopher Hansche
4930-319822521
Manufacturer Reason
for Recall		This recall has been initiated due to the risk of wire splintering after contact with a cautery device during the removal of a lesion. There is a potential risk that wire fragments are not removed during the procedure and stays inside the patient's body.
FDA Determined
Cause 2		Device Design
ActionOn 1/22/2021, Somatex issued an Urgent Medical Device Removal notice to customers via e-mail for Tuflex and Tuflex Premium marking wires. This recall has been initiated due to the risk of wire splintering after contact with a cautery device during the removal of a lesion.
Quantity in Commerce196 pieces
DistributionDomestic: Mo, NJ, OH
Total Product Life CycleTPLC 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.
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