Z-1200-2021 Class II Terminated
FDA device recall Z-1200-2021 was initiated by Somatex Medical Technologies GMBH on February 3, 2021 and is designated Class II. 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 dur… The recall status is terminated (terminated January 13, 2022). Affected quantity: 196 pieces.
Recall Details
- Product Type
- Devices
- Report Date
- March 17, 2021
- Initiation Date
- February 3, 2021
- Termination Date
- January 13, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 196 pieces
Product Description
Thread-like wire marker
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.
Distribution Pattern
Domestic: Mo, NJ, OH
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.