FDAFDA · Food and drugs·Recall number Z-1561-2014
Deknatel Teleflex Medical Silk Black Braided Silk Suture Nonabsorbable Surgical Suture U.S.P. Indicated for use in soft tissue approximation.
Published May 14, 2014 · Recall initiated: March 11, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Teleflex Medical
- Distributor
- Worldwide Distribution -- USA, including the states of 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 countries of Canada, Germany, and Ireland.
- Lot
- Product Code X-6371M5 - Lot 02E0801603
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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