Somatex recalls thread-like wire markers that may splinter during lesion removal, risking retained fragments inside the body. Affected lots include specific reference numbers for Tuflex and Tuflex Premium products.
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.
Somatex is recalling thread-like wire markers that could splinter when used with cautery devices during lesion removal. This poses a risk of wire fragments staying inside the patient's body after surgery.
The wire markers can splinter when contacted with a cautery device during lesion removal. If fragments are not completely removed, they may remain inside the patient's body, causing potential complications.
Patients who have undergone lesion removal procedures using the recalled wire markers are at risk. Medical professionals using these markers for procedures are also affected.
Check the reference numbers on the product packaging: Tuflex has REF 271640-271643 and Tuflex Premium has REF 271650-271652. Affected lots are listed for each reference number.
Review the reference numbers on the product packaging to determine if it is in the affected lots listed for Tuflex or Tuflex Premium.
The recall is due to the risk of wire splintering during lesion removal, which could leave fragments inside the patient's body.
The wire markers may splinter when used with a cautery device, potentially causing retained fragments inside the body.
Check the reference numbers on the packaging: Tuflex has REF 271640-271643 and Tuflex Premium has REF 271650-271652. Affected lots are listed for each reference.
We’ve drafted a message you can send Somatex to request your refund or repair — edit it as you like.
Subject: Recall Z-1200-2021 — Somatex Somatex Hello, I own a Somatex that is covered by recall Z-1200-2021 from Somatex. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
