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Teleflex Medical recalls Deknatel Teleflex Medical Stainless Steel 2 (metric 5) Monofilament Stainless Steel Suture, Nonabsorbable Surgical Sutur
Recalled May 14, 2014 · FDA recall Z-1560-2014 · Teleflex Medical
Hazard
Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use. · FDA Class II
Units
32,271 ea.
Sold at
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.
Description
Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.
Product
Deknatel Teleflex Medical Stainless Steel 2 (metric 5) Monofilament Stainless Steel Suture, Nonabsorbable Surgical Suture, U.S.P. Used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.
Manufacturer(s)
Teleflex Medical
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →