Somatex Thread-like Wire Markers Recalled for Splintering Risk During Cautery
Somatex Medical Technologies is recalling 196 thread-like wire markers due to a risk of wire splintering and retention in the body during cautery procedures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of foreign body retention (wire fragments) in the patient, which constitutes a significant injury risk under the rubric.
Plain-English summary
Somatex Medical Technologies GMBH is recalling 196 pieces of thread-like wire markers. The recall was initiated because the wire markers pose a risk of splintering after contact with a cautery device during the removal of a lesion. This defect creates a potential risk that wire fragments may not be removed during the procedure and could remain inside the patient's body.
The affected products include specific lots of Tuflex and Tuflex Premium wire markers. The recall number is Z-1200-2021. The distribution pattern for these devices is domestic, specifically in Missouri, New Jersey, and Ohio.
Healthcare providers and consumers should stop using the affected wire markers immediately. The source text does not provide specific instructions for disposal or return, but users should contact the recalling firm or their medical device supplier for further guidance on handling the recalled items.
The recalled product
- Product
- Thread-like wire marker
- Manufacturer
- Somatex Medical Technologies GMBH
- Affected units
- 196
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- 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.
Distribution
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