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Recall Observatory FDA recall evidence

Device 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.

Z-1560-2014

March 11, 2014

Class II

Product summary

Firm
Teleflex Medical
Event
Event 67711
Status
Terminated
Classification
Class II
Quantity
32,271 ea.
Official record key
device-enforcement:Z-1560-2014

Official wording

Reason: Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.

Code information: Product Code X-4981M4 - Lot 02J0800451

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.