FDA Medical Device Recalls (openFDA)
Somatex Medical Technologies GMBH: Thread-like wire marker
- Recall number
- Z-1200-2021
- Recalling firm
- Somatex Medical Technologies GMBH
- Product
- Thread-like wire marker
- Status
- Terminated
- Initiated
- 2021-02-03
- Posted
- not on file
- Terminated
- 2022-01-13
- 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.
- Root cause
- Device Design
- Action
- On 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
- 196 pieces
- Distribution
- Domestic: Mo, NJ, OH
- Lot, serial or model codes
- 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.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MIJ
- Firm FEI
- 1000408433
- Firm city
- Berlin
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28