Somatex Medical Technologies GMBH Recall 87317
Description: Thread-like wire marker
Somatex Medical Technologies GMBH Recall 87317 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1200-2021 |
| Event ID | 87317 |
| Event Description | Thread-like wire marker |
| Product Type | Devices |
| Distribution | Domestic: Mo, NJ, OH |
| Quantity | 196 pieces |
| Recall Reason | 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. |
| Device Classification | 20210317 |
| Device Code Info | 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. |
| Center Classification Date | 20210310 |
| Recall Initiation Date | 20210203 |
| Recalling Firm | Somatex Medical Technologies GMBH |
| Initial Notification | |
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