Teleflex Medical Recalls Silk Sutures Due to Needle Detachment Risk
Teleflex Medical is recalling specific lots of Deknatel Silk Sutures because the needle may detach from the suture during use.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as a Class II recall. The hazard involves a surgical instrument failing during a procedure (needle detachment), which poses a significant risk of injury to the patient, fitting the 'Severe' criteria for significant injury reports or high-risk device defects.
Plain-English summary
Teleflex Medical is recalling 32,271 units of Deknatel Silk Black Braided Silk Suture, Product Code X-6371M5, Lot 02E0801603. The recall was initiated because the product does not meet minimum needle attachment strength requirements.
The hazard is that the needle can become detached from the suture during use. This nonabsorbable surgical suture is indicated for use in soft tissue approximation.
The affected product was distributed worldwide, including in the United States (specifically AL, CA, FL, GA, IL, IN, KS, LA, ME, MA, MI, MN, MS, MO, NV, NJ, NM, NY, OH, PA, RI, SC, TN, TX, UT, VA, WV, and WI) and in Canada, Germany, and Ireland. Healthcare providers and facilities should stop using the affected lots and contact Teleflex Medical for further instructions.
The recalled product
- Product
- Deknatel Teleflex Medical Silk Black Braided Silk Suture Nonabsorbable Surgical Suture U.S.P. Indicated for use in soft tissue approximation.
- Manufacturer
- Teleflex Medical
- Affected units
- 32,271
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 (1)
- Product Code X-6371M5 - Lot 02E0801603
Distribution
Part of a larger recall action
This product is one of 7 recalled by Teleflex Medical under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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